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AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves

Thursday, May 25, 2017


Clinical Trials

2013 Clinical Trials Award $ 50,000 Deadline - January 1, 2013

NREF Grant Assistance Program - Deadline October 1, 2012

For further questions regarding both of these programs please contact Zoher Ghogawala, MD

Grant Information and Courses


A Clinical Study of the GO-LIF® Approach for Lumbar Spinal Fixation
A Clinical Study of the GO-LIF® Approach for Lumbar Spinal Fixation
http://www.clinicaltrials.gov/ct/show/NCT00810433

Objective: Collect data regarding the safety and feasibility of the GO-LIF procedure for spinal fixation and stabilization, in conjunction with conventional approaches for interbody lumbar fusion. This is in order to allow for evidence-based comparison to pedicle-screw-based techniques.

Design: Interventional; safety/efficacy; single group assignment; open-label; treatment.

Enrollment: Enrollment: 40



A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
http://www.clinicaltrials.gov/ct/show/NCT01182337

Objective: Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.

Design: Interventional; randomized; placebo control; safety/efficacy; parallel assignment; double blind (subject; investigator).

Enrollment: Enrollment: 30



A Multicenter Prospective Study of Quality of Life in Adult Scoliosis (ASLS)
A Multicenter Prospective Study of Quality of Life in Adult Scoliosis (ASLS)
http://www.clinicaltrials.gov/ct/show/NCT00854828

Objective: Evaluate the effectiveness of non-operative and operative treatments.

Design: Randomized, safety/efficacy; parallel assignment; open label; Treatment.

Enrollment: 300



A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration
A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration
http://www.clinicaltrials.gov/ct/show/NCT01124006

Objective: Show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.

Design: Interventional; randomized; placebo control; safety/efficacy; crossover assignment; double blind (subject; investigator); treatment.

Enrollment: Enrollment: 30



A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
http://www.clinicaltrials.gov/ct/show/NCT00401518

Objective: To determine if the ACADIA™ Facet Replacement System is effective in the treatment of spinal stenosis. Evaluate overall success rate of Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal fusion control.

Design: Interventional; randomized; active control; safety/efficacy; parallel assignment; single blind; treatment.

Enrollment: 300



A Post Market Surveillance Validation to evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System
A Post Market Surveillance Validation to evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System
http://www.clinicaltrials.gov/ct/show/NCT01220505

Objective: Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System

Design: Observational; case only; prospective.

Enrollment: 200



A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
http://www.clinicaltrials.gov/ct/show/NCT01461005

Objective: Post-Market Surveillance study is to evaluate safety.

Design: Interventional; endpoint classification study; single group assignment; open label; treatment.

Enrollment: 150



A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine (MASTERS-D)
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine (MASTERS-D)
http://www.clinicaltrials.gov/ct/show/NCT01143324

Objective: Observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF (Transforaminal Lumbar Interbody Fusion) techniques for the treatment of the degenerative lumbar spine in a "real-world" patient population.

Design: Observational: case-only; prospective

Enrollment: Enrollment: 200



A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
http://www.clinicaltrials.gov/ct/show/NCT00697827

Objective: Evaluate safety and effectiveness of the In-Space compared to the X-STOP Interspinous Process distraction device for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two levels.

Design: Treatment; randomized; parallel assignment; safety/efficacy study.

Enrollment: 500



Accuracy of Lumbar Pedicle Screw Placement Assisted With Continuous Pulse-train Stimulation
Accuracy of Lumbar Pedicle Screw Placement Assisted With Continuous Pulse-train Stimulation
http://www.clinicaltrials.gov/ct/show/NCT01342588

Objective: Establish the accuracy of pedicle positioning using continuous electrical pulse during screw placement.

Design: Interventional; safety/efficacy; single group assignment; open label; supportive care.

Enrollment: 60



Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion (APPRAISET1)
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion (APPRAISET1)
http://www.clinicaltrials.gov/ct/show/NCT01013389

Objective: Evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion. The secondary objective of this clinical trial is to assess clinical outcome measurements

Design: Interventional; randomized; parallel assignment; single blind (subject); treatment.

Enrollment: Enrollment: 100



Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment in the Treatment of Degenerative Disc Disease
Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment in the Treatment of Degenerative Disc Disease
http://www.clinicaltrials.gov/ct/show/NCT00589797

Objective: To learn whether an investigational device called the Activ™-L Artificial Disc is safe and effective in the treatment of degenerative disc disease of the lower (lumbar) spine.

Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study.

Enrollment: 414



An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)
An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)
http://www.clinicaltrials.gov/ct/show/NCT01019057

Objective: Evaluate ILIF™ to similar procedures.

Design: Interventional; non-randomized; uncontrolled; safety/efficacy; single group assignment; open label; treatment.

Enrollment: Enrollment: 50



Anterior vs. Posterior Procedures for Cervical Spondylotic Myelopathy: Prospective Randomized Trial (CSM)
Anterior vs. Posterior Procedures for Cervical Spondylotic Myelopathy: Prospective Randomized Trial (CSM)
http://www.clinicaltrials.gov/ct/show/NCT00876603

Objective: There is no difference in surgical outcomes for patients suffering from cervical spondylotic myelopathy treated with anterior decompression and fusion or posterior cervical laminoplasty.

Design: Cohort, Prospective

Enrollment: 100



Application of High Resolution Diffusion-weighted MR Imaging Pulse Sequence in Brain, Head and Neck, and Spine Cancer
Application of High Resolution Diffusion-weighted MR Imaging Pulse Sequence in Brain, Head and Neck, and Spine Cancer
http://clinicaltrials.gov/ct2/show/NCT01535898?term=spine&rank=54

Objective: Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if a new MR imaging method can help tumor evaluation in head and neck cancer or spine metastases or primary or secondary brain tumors. The extra images will be obtained using Diffusion-weighted Magnetic Resonance Imaging which provides image contrast through detection of small restrictions in the movement of water molecules. This study may help us provide additional information about the tumor along with the picture of the organ.

Design: Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic

Enrollment:



Arthroplasty versus Fusion in Anterior Cervical Surgery:Prospective Study of the Impact on the Adjacent Level.
Arthroplasty versus Fusion in Anterior Cervical Surgery:Prospective Study of the Impact on the Adjacent Level.
http://www.clinicaltrials.gov/ct/show/NCT00554528

Objective: evaluate impact of cervical disk surgery on the deterioration of adjacent levels.

Design: Treatment; randomized; open label; active control; factorial assignment; efficacy study.

Enrollment: 220



Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
http://www.clinicaltrials.gov/ct/show/NCT00310440

Objective: Evaluate if P-15 bone putty is not inferior in effectiveness and safety to DBX when applied in instrumented anterior cervical discectomy and fusion with use of a structural allograft ring in patients with degenerative cervical disc disease.

Design: Treatment, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study

Enrollment: 204



Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer
Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer
http://www.clinicaltrials.gov/ct/show/NCT01407341

Objective: Studies beta-tricalcium phosphate bone graft in treating patients undergoing surgery for metastatic spine cancer. A bone graft may help healing and bone growth in patients undergoing surgery for spine cancer.

Design: Non-Randomized; Efficacy Study; Single Group Assignment; Open Label; Supportive Care.

Enrollment: 20



Bone Graft Materials Observational Registry (APPROACH-001)
Bone Graft Materials Observational Registry (APPROACH-001)
http://www.clinicaltrials.gov/ct/show/NCT00974623

Objective: Collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.

Design: Cohort, Prospective

Enrollment: 300



Center Blade Study
Center Blade Study
http://www.clinicaltrials.gov/ct/show/NCT01499680

Objective: Evaluate intraoperative neuromonitoring results in subjects who undergo eXtreme Lateral Interbody Fusion (XLIF) surgery at any number of levels inclusive of L4-5.

Design: Observational; case control; prospective.

Enrollment: 300



Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
http://www.clinicaltrials.gov/ct/show/NCT00868335

Objective: Find out if use of a cervical disc prosthesis in the treatment of a cervical disc herniation preserves or restores normal mobility and movement in the cervical spine.

Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Enrollment: 24



Clinical Evaluation of the Crosstrees Pod™ in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4-L5) in Adult Patients
Clinical Evaluation of the Crosstrees Pod™ in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4-L5) in Adult Patients
http://www.clinicaltrials.gov/ct/show/NCT00933036

Objective: Evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.

Design: Interventional; non-randomized; safety/efficacy; single group assignment; open label; treatment.

Enrollment: 118



Clinical Outcome Study of Minimally Invasive Decompression for Lumbar Spinal Stenosis (MEDLLSS)
Clinical Outcome Study of Minimally Invasive Decompression for Lumbar Spinal Stenosis (MEDLLSS)
http://www.clinicaltrials.gov/ct/show/NCT00737607

Objective: Evaluate effectiveness and treatment outcomes of endoscopic decompressive laminotomy with objective evaluation tools.

Design: Case only; prospective

Enrollment: 60



Clinical Outcomes of the Trinica(r) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Clinical Outcomes of the Trinica(r) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
http://www.clinicaltrials.gov/ct/show/NCT00762723

Objective: Collect clinical outcomes data, including a comparison of different screw configurations, is needed to support the use of the Trinica(r) ALP System.

Design: Open label, parallel assignment, randomized, treatment

Enrollment: 120



Clinical Outcomes Study Evaluating the Zero-P PEEK
Clinical Outcomes Study Evaluating the Zero-P PEEK
http://www.clinicaltrials.gov/ct/show/NCT00945243

Objective: Evaluate the maintenance or improvement of the Neck Disability Index (NDI) scores in patients undergoing single-level anterior cervical discectomy and fusion (ACDF) for SCDD using the Zero-P PEEK device.

Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Enrollment: 114



Clinical Trial Comparing Decompression With and Without Coflex™ Treating Lumbar Spinal Stenosis
Clinical Trial Comparing Decompression With and Without Coflex™ Treating Lumbar Spinal Stenosis
http://www.clinicaltrials.gov/ct/show/NCT01316211

Objective: Verification of an improvement in the clinical outcome according to low back pain occurrence in patients with coflex™ implant compared to patients without coflex™ implant.

Design: Interventional; randomized; safety/efficacy; parallel assignment; open label treatment.

Enrollment: 230



Clinical Trial of Gabapentin to Improve Postoperative Pain in Surgical Patients
Clinical Trial of Gabapentin to Improve Postoperative Pain in Surgical Patients
http://www.clinicaltrials.gov/ct/show/NCT00221338

Objective: Patients will be randomized to receive either placebo or gabapentin preoperatively, and continued postoperatively until discharge; using an intention to treat strategy, we, the researchers at UCSF, will compare the amount of postoperative pain, narcotic requirements, and postoperative delirium and cognitive dysfunction between the two groups.

Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Enrollment: 312



Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
http://www.clinicaltrials.gov/ct/show/NCT00939406

Objective: Phase II trial to evaluate safety and efficacy of Hyalospine® in patients undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk herniation. The device is an adjunct in lumbar spine surgery to prevent post-surgical fibrosis and adhesions.

Design: Interventional; randomized; uncontrolled; safety/efficacy; parallel assignment; double blind; Treatment.

Enrollment: 50



Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients
Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients
http://clinicaltrials.gov/ct2/show/NCT01566422?term=spine&rank=94

Objective: In this proposal the investigators will prospectively randomize patients undergoing posterior spinal stabilization for traumatic injuries into either receiving vancomycin powder into the surgical site (treatment) versus not receiving vancomycin powder (control) and subsequently follow infection rate, complications, and cost of care. The investigator's hypothesis is that i) vancomycin powder will decrease infection rates ii) have no systemic toxicity iii) and be a cost saving advancement in the safety of delivering spine surgical care.

Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)

Enrollment:



Comparative Study of Balloon Kyphoplasty and Coservative Treatment (TRAMAA 1-2-3)
Comparative Study of Balloon Kyphoplasty and Coservative Treatment (TRAMAA 1-2-3)
http://www.clinicaltrials.gov/ct/show/NCT00749242

Objective: Compare two treatments in acute stable traumatic vertebral fractures

Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Enrollment: 200



Comparison of Balloon Kyphoplasty and Vertebroplasty in Subacute Osteoporotic Vertebral Fractures (OSTEO+6)
Comparison of Balloon Kyphoplasty and Vertebroplasty in Subacute Osteoporotic Vertebral Fractures (OSTEO+6)
http://www.clinicaltrials.gov/ct/show/NCT00749086

Objective: Compare two treatments in subacute (more than 6 week duration) non-traumatic (usually osteoporotic) vertebral fractures.

Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Enrollment: 200



Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures
Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures
http://www.clinicaltrials.gov/ct/show/NCT00749060

Objective: Compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.

Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Enrollment: 300



Comparison of Cage Versus Plate in One Level Cervical Disc Disease
Comparison of Cage Versus Plate in One Level Cervical Disc Disease
http://www.clinicaltrials.gov/ct/show/NCT01011569

Objective: Compare 2 surgical methods for single for one-level cervical disc disease; cage only and plate/graft.

Design: Observational Model: CohortTime Perspective: Prospective

Enrollment: 80



Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
http://www.clinicaltrials.gov/ct/show/NCT00432159

Objective: Compare safety and effectiveness of the DISCOVER™ Artificial Cervical Disk and ACDF in the treatment of DDD in 1 or 2 adjacent levels in the cervical spine C3-C7.

Design: Treatment, randomized, single blind, active control, parallel assignment, safety/efficacy study.

Enrollment: 820



Comparison of Outcomes Between Early Physical Therapy Intervention and Usual Care Following Anterior Cervical Fusion Surgery
Comparison of Outcomes Between Early Physical Therapy Intervention and Usual Care Following Anterior Cervical Fusion Surgery
http://clinicaltrials.gov/ct2/show/NCT01519115?term=spine&rank=14

Objective: The purpose of this study is to compare the effectiveness of clinical outcomes between an early PT intervention and usual care in patients who have undergone anterior cervical spine fusion (ACF) surgery. A study hypothesis is that outcomes will be improved with early PT intervention.

Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Enrollment:



Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine
Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine
http://clinicaltrials.gov/ct2/show/NCT01224379?term=spine&rank=61

Objective: Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?

Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label

Enrollment:



Condition of Approval Study (COAST)
Condition of Approval Study (COAST)
http://www.clinicaltrials.gov/ct/show/NCT00517751

Objective: Study designed to supplement pre-market safety/effectiveness data with information on long-term device performance.

Design: Non-randomized; open-label; safety/efficacy study; single group assignment; treatment; uncontrolled.

Enrollment: 240



Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine
Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine
http://clinicaltrials.gov/ct2/show/NCT01654068?term=spine&rank=81

Objective: The purpose of this study is to determine if Conformal High Dose Intensity Modulated Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal column. This study involves patients who have been diagnosed with metastatic cancer to the thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the area of concern. The goal is to prove that this is not only a safe form of treatment, but that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer coming back in the area that the investigators treat which may reduce the risk of developing symptoms like pain in the future.

Design: Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label

Enrollment:



CopiOs Posterolateral Fusion Procedure
CopiOs Posterolateral Fusion Procedure
http://www.clinicaltrials.gov/ct/show/NCT01123850

Objective: Compare radiographic data collection from patients undergoing instrumented PLF with CopiOs (R) BVF or instrumented PLF with autologous bone and to assess overall clinical outcomes.

Design: observational; cohort; prospective.

Enrollment: 85



Diffusion Tensor (Magnetic Resonance) Imaging and Tractography in Herniation of the Cervical Spine
Diffusion Tensor (Magnetic Resonance) Imaging and Tractography in Herniation of the Cervical Spine
http://clinicaltrials.gov/ct2/show/NCT00599183?term=spine&rank=16

Objective: This is an investigator-iniated pilot study to determine if MRI with diffusion tensor imaging (DTI) and tractography will yield useful information in patients suspected of having cervical spine disc herniation to provide imaging confirmation of whether or not disease is progressing and to assess response to treatment (regardless of treatment provided).

Design: Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic

Enrollment:



Direct Stimulation of Spinal Nerve Roots to Determine Sensory and Motor Innervation Patterns
Direct Stimulation of Spinal Nerve Roots to Determine Sensory and Motor Innervation Patterns
http://www.clinicaltrials.gov/ct/show/NCT00696501

Objective: Collect and analyze data while monitoring muscles and nerves during spine surgery to develop a map of human muscle innervations patterns.

Design: Cohort; prospective.

Enrollment: 1,000



Dose-Dense Temozolomide and Lapatinib for Recurrent Ependymoma
Dose-Dense Temozolomide and Lapatinib for Recurrent Ependymoma
http://www.clinicaltrials.gov/ct/show/NCT00826241

Objective: To learn if Lapatinib given in combination with Temozolomide can help control recurrent ependymoma.

Design: Interventional; single group assignment; open label; treatment.

Enrollment: 50



DuraSeal Exact Spine Sealant System Post-Approval Study
DuraSeal Exact Spine Sealant System Post-Approval Study
http://clinicaltrials.gov/ct2/show/NCT01410864?term=spine&rank=37

Objective: This is a non-randomized, post-approval study to further evaluate the rate of post-operative CSF leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System

Design: Observational Model: Cohort

Enrollment:



Effect of Human Thrombin With Gelatin Matrix on Perioperative Blood Loss in Scoliosis Surgery
Effect of Human Thrombin With Gelatin Matrix on Perioperative Blood Loss in Scoliosis Surgery
http://www.clinicaltrials.gov/ct/show/NCT01451788

Objective: Clinical trial comparing Gelatin matrix with human derived thrombin (Floseal, Baxter) and without use of Floseal in adolescents undergoing posterior spinal deformity surgery for AIS (adolescent idiopathic scoliosis between 45 and 90 degrees).

Design: Interventional; randomized; efficacy; parallel assignment; single blind (subject); treatment.

Enrollment: 60



Effectiveness of Lumbar Fusion When NanOss Bioactive Is Used With Posterolateral Gutter Fusions
Effectiveness of Lumbar Fusion When NanOss Bioactive Is Used With Posterolateral Gutter Fusions
http://www.clinicaltrials.gov/ct/show/NCT01452516

Objective: Evaluate the use of nanOss Bioactive for intertransverse process posterolateral fusions.

Design: Observational; case study; prospective.

Enrollment: 100



Efficacy and Safety of Accell Evo3 DBM in Instrumented Posterolateral Lumbar Spine Fusion
Efficacy and Safety of Accell Evo3 DBM in Instrumented Posterolateral Lumbar Spine Fusion
http://www.clinicaltrials.gov/ct/show/NCT01430299

Objective: Evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient cohort.

Design: Interventional; non-randomized; safety/efficacy; single group assignment; open label; treatment.

Enrollment: 30



Efficacy and Safety Study of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Bone Marrow (MatriBone)
Efficacy and Safety Study of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Bone Marrow (MatriBone)
http://www.clinicaltrials.gov/ct/show/NCT01335243

Objective: Estimate the rate of intersomatic fusion observed 12 months after lumbar interbody fusion by posterior approach with PEEK interbody cage of fusion in PEEK performed with autologous bone of decortication and osseous substitute with a biomaterial (MatriBONE associated with the autologous bone marrow), associated with a posterolateral bone graft performed with MatriBone waxed with bone marrow. Indication is dedicated for patients by painful degenerative osteoarthritis, by narrow lumbar canal and\or spondylolisthesis.

Design: Efficacy Study; Single Group Assignment; Open Label; Treatment

Enrollment: 82



Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients with Malignant Spinal Cord Compression
Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients with Malignant Spinal Cord Compression
http://www.clinicaltrials.gov/ct/show/NCT00624507

Objective: Assess and evaluate the efficacy of re-irradiation in patients presenting with malignant spinal cord compression occurring in a previously irradiated area of the spinal cord.

Design: Treatment; non-randomized; open label; dose comparison; parallel assignment; safety/efficacy study.

Enrollment: 40



Efficacy of Riluzole in Surgical Treatment of Cervical Spondylotic Myelopathy (CSM-Protect)
Efficacy of Riluzole in Surgical Treatment of Cervical Spondylotic Myelopathy (CSM-Protect)
http://www.clinicaltrials.gov/ct/show/NCT01257828

Objective: Evaluate the potential benefit of adding a neuroprotective drug which aids in the treatment of patients with CSM whom are undergoing surgical decompression.

Design: Interventional; efficacy; parallel assignment; double blind (subject; investigator; outcome assessor).

Enrollment: 270



Efficacy of the Aspen Spinous Process System in Anterior Lumbar Interbody Fusion (ALIF)
Efficacy of the Aspen Spinous Process System in Anterior Lumbar Interbody Fusion (ALIF)
http://www.clinicaltrials.gov/ct/show/NCT01016314

Objective: Evaluate the clinical outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental posterior fixation using ASPEN Spinous Process System compared to pedicle screw instrumentation.

Design: Interventional; randomized; parallel assignment; open label; treatment.

Enrollment: Enrollment: 156



Establishment of a Brain and Spinal Cord Tissue Bank
Establishment of a Brain and Spinal Cord Tissue Bank
http://www.clinicaltrials.gov/ct/show/NCT00686387

Objective: Establish a Brain and Spinal Tumor Tissue/Specimen repository to serve as a resource for current and future scientific studies.

Design: Observational Model: Case-Only; Time Perspective: Prospective

Enrollment: 70



Evaluate Initial Safety of the HemiBridge™ System in Guided Spinal Growth Treatment of Progressive Idiopathic Scoliosis
Evaluate Initial Safety of the HemiBridge™ System in Guided Spinal Growth Treatment of Progressive Idiopathic Scoliosis
http://www.clinicaltrials.gov/ct/show/NCT01465295

Objective: Study a new method of treatment for patients who are diagnosed with idiopathic scoliosis and have abnormal and increasing curvature of the spine. The treatment consists of the surgical implantation of a new medical device called the "HemiBridge™ Clip". This procedure is intended to stop additional curvature of the spine by redirecting growth of the bones of the spine (vertebrae).

Design: Interventional; safety; single group assignment; open label; treatment.

Enrollment: 6



Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)
Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)
http://www.clinicaltrials.gov/ct/show/NCT00508443

Objective: Establish safety/feasibility of using novel CT-on-Rails or Trilogy stereotactic spine radiotherapy system to treat spine and para-spinal tumors.

Design: Treatment, non-randomized, open label, uncontrolled, single group assignment, safety/efficacy study.

Enrollment: 150



Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis (FLUORONAV)
Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis (FLUORONAV)
http://www.clinicaltrials.gov/ct/show/NCT01335841

Objective: Demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy

Design: Interventional; randomized; safety/efficacy; parallel assignment; single-blind (subject); treatment.

Enrollment: 150



Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
http://www.clinicaltrials.gov/ct/show/NCT00984672

Objective: Excess bone overgrowth around the spinal nerves in proximity to the fusion cage has been reported. No prospective studies have been performed assessing the incidence and etiology of this complication. The investigators propose a prospective study evaluating the incidence of this complication as well as postoperative imaging studies to help determine whether bony overgrowth is indeed occurring adjacent to the effected spinal nerves.

Design: Observational; case-control; prospective

Enrollment: Enrollment: 240



Evaluation of Single Session Stereotactic Body Radiotherapy
Evaluation of Single Session Stereotactic Body Radiotherapy
http://www.clinicaltrials.gov/ct/show/NCT00492817

Objective: Establish safety and efficacy of using stereotactic body radiotherapy to treat spine and paraspinal tumors in a single session.

Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.

Enrollment: 60



Evaluation of the Safety of C-Spine Clearance by Paramedics
Evaluation of the Safety of C-Spine Clearance by Paramedics
http://clinicaltrials.gov/ct2/show/NCT01188447?term=spine&rank=3

Objective: The goal of this cohort study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients with the Canadian C-Spine Rule (CCR) and transport them to the Emergency Department without immobilization. The specific objectives of the study are to determine safety, determine the clinical impact and evaluate performance.

Design: Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic

Enrollment:



Feasibility Study of NL-Prow Interspinous Spacer to Treat Lumbar Spinal Stenosis
Feasibility Study of NL-Prow Interspinous Spacer to Treat Lumbar Spinal Stenosis
http://www.clinicaltrials.gov/ct/show/NCT01053364

Objective: Evaluate the clinical safety and feasibility of the NL-Prow™ Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal stenosis

Design: Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment

Enrollment: 6



Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease (FLD)
Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease (FLD)
http://www.clinicaltrials.gov/ct/show/NCT00775801

Objective: The study will compare the safety and effectiveness of the FLD artificial lumbar disc to an already approved artificial lumbar disc.

Design: Interventional; randomized; safety/efficacy; parallel assignment; open label; treatment.

Enrollment: Enrollment: 300



Fusion Assessment Clinical Trial (FACT)
Fusion Assessment Clinical Trial (FACT)
http://www.clinicaltrials.gov/ct/show/NCT00736398

Objective: Assess clinical outcomes in patients who undergo spinal fusion.

Design: Cohort; prospective

Enrollment: 50



Gait and Postural Stability Assessment in Children With Idiopathic Scoliosis Undergoing Posterior Spine Instrumentation
Gait and Postural Stability Assessment in Children With Idiopathic Scoliosis Undergoing Posterior Spine Instrumentation
http://clinicaltrials.gov/ct2/show/NCT01109082?term=spine&rank=33

Objective: The goal of this study is to evaluate children and adolescents with idiopathic scoliosis who are undergoing spinal fusion using motion analysis, balance, and outcome questionnaires. Little research has been done to evaluate how different fusion levels impact walking patterns, range of motion, posture and balance following spine instrumentation in children with idiopathic scoliosis. Debate still continues whether posterior spinal instrumentation with the last instrumented vertebra at or above Lumbar 3 (L3) will provide sufficient spine correction, greater motion, and better posture and balance when compared to a child with instrumentation at Lumbar 4 (L4). Furthermore, how does the spine fusion endpoint (last instrumented vertebra) impact quality of life, participation, and impairment in children and adolescents with idiopathic scoliosis and how do they compare to healthy age-matched peers. The goal of this study is to compare these two end points using gait analysis, postural stability, and outcome tools with the hopes of providing better clinical care to children with idiopathic scoliosis.

Design: Observational Model: Cohort Time Perspective: Prospective

Enrollment:



Genetic Determinants of Ankylosing Spondylitis Severity- Longitudinal Study
Genetic Determinants of Ankylosing Spondylitis Severity- Longitudinal Study
http://www.clinicaltrials.gov/ct/show/NCT00056719

Objective: Explore how genes may influence the severity of ankylosing spondylitis, a form of arthritis that affects the spine. Patients have inflammation of the joints of the spine, which may cause the bones of the spine to fuse, resulting in difficulty performing daily activities.

Design: Natural History

Enrollment: 300



Greenwich Lumbar Stenosis SLIP Study
Greenwich Lumbar Stenosis SLIP Study
http://www.clinicaltrials.gov/ct/show/NCT00109213

Objective: determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis).

Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Enrollment: 75



IDE Clinical Trial Comparing Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
IDE Clinical Trial Comparing Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
http://www.clinicaltrials.gov/ct/show/NCT00534235

Objective: To evaluate the safety and effectiveness of coflex device compared to control.

Design: Randomized, double-blind, parallel assignment, safety/efficacy study.

Enrollment: 460



Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine (MicroSpine)
Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine (MicroSpine)
http://www.clinicaltrials.gov/ct/show/NCT01266200

Objective: In this project, with unstable vertebral fractures, the microcirculation of the skin and muscle (O2C, Laser-Doppler/White-light -Spectroscopy and contrast-enhanced sonography) will be evaluated in both conventional and in percutaneous minimally invasive technique (XIA versus Mantis) at the thoracolumbar junction.

Design: Interventional; randomized; single group assignment; single blind (outcomes assessor); treatment.

Enrollment: 100



Impact of Impaired Cerebral Autoregulation on Postoperative Delirium in Elderly Patients Undergoing Spine Surgery
Impact of Impaired Cerebral Autoregulation on Postoperative Delirium in Elderly Patients Undergoing Spine Surgery
http://clinicaltrials.gov/ct2/show/NCT01574950?term=spine&rank=41

Objective: Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. There is very little information available about how often delirium occurs and the complications associated with it. Elderly patients are at high risk for delirium after surgery. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. The results from this study will provide important information on a possible mechanism and predictor of delirium.

Design: Observational Model: Cohort Time Perspective: Prospective

Enrollment:



Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury
Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury
http://www.clinicaltrials.gov/ct/show/NCT00583804

Objective: Evaluate effectiveness of an implanted stimulator and sensor for providing hand and arm function for individuals with cervical level spinal cord injury.

Design: Treatment; open-label; single group assignment; safety/efficacy study.

Enrollment: 50



Improvement of Transoperatory X-ray Visualization During Anterior Cervical Surgery
Improvement of Transoperatory X-ray Visualization During Anterior Cervical Surgery
http://www.clinicaltrials.gov/ct/show/NCT01342575

Objective: Establish which of five different maneuvers could bring the best trans-operatory x-ray exposure during anterior cervical surgeries with the higher security

Design: Interventional; safety/efficacy; single group assignment; open label; supportive care.

Enrollment: 50



Infuse® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate Pivotal Clinical Trial
Infuse® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate Pivotal Clinical Trial
http://www.clinicaltrials.gov/ct/show/NCT00485173

Objective: Establish safety/effectiveness of Infuse®Bone Graft, the PEEK Interbody Spacer, and anterior cervical plate in patients with cervical DDD.

Design: Treatment, non-randomized, open label, historical control, single group assignment, safety/efficacy study.

Enrollment: 225



Infuse® Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
Infuse® Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
http://www.clinicaltrials.gov/ct/show/NCT01415908

Objective: Provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels from L2-S1 to treat subjects with advanced degenerative disease of the lumbosacral spine.

Design: Non-randomized; safety/efficacy; parallel assignment; open label, treatment

Enrollment: 534



Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion (DEXREDLOS)
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion (DEXREDLOS)
http://www.clinicaltrials.gov/ct/show/NCT0080866

Objective: Evaluate whether DEX can help get patients out of the hospital faster after major spine surgery by reducing the inflammation associated with the procedure itself.

Design: Interventional; randomized; pharmacodynamics study; parallel assignment; double blind (subject, caregiver; investigator; outcomes/assessor); treatment.

Enrollment: 200



Investigating Superion™ In Spinal Stenosis (ISISS)
Investigating Superion™ In Spinal Stenosis (ISISS)
http://www.clinicaltrials.gov/ct/show/NCT00692276

Objective: Designed to evaluate the safety and effectiveness of Superion™ ISS compared to the XSTOP®IDP® device in healthy adults with moderate spinal stenosis symptoms who have been unresponsive to conservative care.

Design: Treatment; randomized; open label; active control; parallel assignment; safety/efficacy study.

Enrollment: 400



Kineflex-C Artificial Disc System to Treat Cervical DDD
Kineflex-C Artificial Disc System to Treat Cervical DDD
http://www.clinicaltrials.gov/ct/show/NCT00374413

Objective: The Kineflex-C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 toC7

Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Bio-equivalence Study

Enrollment: 350



Kypho-IORT: Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases
Kypho-IORT: Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases
http://www.clinicaltrials.gov/ct/show/NCT01280032

Objective: Define the maximum tolerable dose (MTD) for IORT during a kyphoplasty using specific MTD-criteria and evaluating the effectiveness of this combined treatment procedure. To determine the MTD 3 levels with increasing doses are planned.

Design: Interventional; safety/efficacy; single group assignment; open label; treatment.

Enrollment: 18



LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
http://clinicaltrials.gov/ct2/show/NCT00389597?term=spine&rank=60

Objective: The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device. The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels. Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nerve/spinal cord compression despite continued non-operative conservative treatment.

Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)

Enrollment:



Lumbar Disc Herniation Outcome Measures
Lumbar Disc Herniation Outcome Measures
http://www.clinicaltrials.gov/ct/show/NCT01041391

Objective: Examine outcome measurements on patients who undergo surgery to remove a damaged lumbar disc versus those who do not have surgery.

Design: Observational; case control; prospective.

Enrollment: 200



Lumbar Interbody Fusion Using the TelamonPeek Versus the Telamon Hydrosorb Fusion Device
Lumbar Interbody Fusion Using the TelamonPeek Versus the Telamon Hydrosorb Fusion Device
http://www.clinicaltrials.gov/ct/show/NCT00095095

Objective: Comparison of two fusion devices

Design: Treatment, randomized, single blind, uncontrolled, parallel assignment, safety/efficacy study

Enrollment: 210



Lumbar Spinal Fusion System
Lumbar Spinal Fusion System
http://www.clinicaltrials.gov/ct/show/NCT00758719

Objective: Evaluate effectiveness of the Biomet Lumbar Spinal Fusion System

Design: Prospective

Enrollment: 480



Lumbar to Sacral Ventral Nerve Re-Routing
Lumbar to Sacral Ventral Nerve Re-Routing
http://www.clinicaltrials.gov/ct/show/NCT00378664

Objective: Assess level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in spinal cord injury and spina bifida patients.

Design: Treatment; non-randomized; open label; uncontrolled; single group assignment; efficacy study.

Enrollment: none given



Magnetic Resonance Imaging (MRI) Interpretations for Lumbar Spinal Stenosis (LSS)
Magnetic Resonance Imaging (MRI) Interpretations for Lumbar Spinal Stenosis (LSS)
http://www.clinicaltrials.gov/ct/show/NCT01017692

Objective: Establish a relationship between the degree of radiologically established anatomical stenosis and the severity of self-assessed outcome measures in patients that have undergone and MRI.

Design: Observational Model: CohortTime Perspective: Prospective

Enrollment: 100



Mild® Decompression Alternative to Open Surgery Epidural Steroid Injection Comparative Outcomes Study
Mild® Decompression Alternative to Open Surgery Epidural Steroid Injection Comparative Outcomes Study
http://www.clinicaltrials.gov/ct/show/NCT01315145

Objective: Compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.

Design: Interventional; randomized; parallel assignment; open label; treatment

Enrollment: 200



Natural History Study of Patients with Neurofibromatosis Type 2
Natural History Study of Patients with Neurofibromatosis Type 2
http://www.clinicaltrials.gov/ct/show/NCT00598351

Objective: Examine over the long-term progress of patients with neurofibromatosis type 2 to learn how fast their tumors grow and if certain factors might affect their growth. Examines effects of tumors on patient's activities of daily living.

Design: Observational; prosective.

Enrollment: 250



Neurogenic Intermittent Claudication Evaluation Study (NICE)
Neurogenic Intermittent Claudication Evaluation Study (NICE)
http://www.clinicaltrials.gov/ct/show/NCT00905359

Objective: Provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication, relieved by flexion. Allocation: Randomized

Design: Allocation: RandomizedEndpoint Classification: Efficacy StudyIntervention Model: Parallel Assignment Masking: Open Label;Primary Purpose: Treatment

Enrollment: 280



Neurosurgery Patient Outcomes in Treating Spinal Disorders (Neuropoint-SD)
Neurosurgery Patient Outcomes in Treating Spinal Disorders (Neuropoint-SD)
http://www.clinicaltrials.gov/ct/show/NCT01220921

Objective: The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices to evaluate outcomes after spine surgery in patients with symptomatic lumbar disc herniation and Grade I Spondylolisthesis.

Design: Non-randomized; safety/efficacy; parallel assignment; open label; health services research.

Enrollment: Enrollment: 200



Optimal Treatment for Spinal Cord Injury Associated with Cervical Canal Stenosis (OSCIS) Study
Optimal Treatment for Spinal Cord Injury Associated with Cervical Canal Stenosis (OSCIS) Study
http://www.clinicaltrials.gov/ct/show/NCT01485458

Objective: Compare two strategies: early surgery within 24 hours after admission and delayed surgery following at least 2 weeks of conservative treatment. The purpose of this study is to examine whether early surgery would result in greater improvement in motor function as compared with delayed surgery.

Design: Interventional; randomized; safety/efficacy; parallel assignment; open label; treatment.

Enrollment: 100



OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture
OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture
http://www.clinicaltrials.gov/ct/show/NCT00961714

Objective: Provide reasonable assurance on safety and effectiveness of the OsseoFix Spinal Fracture Reduction System for market release approval in the US. This investigational device is intended to restore biomechanical integrity to a vertebral body that has suffered a painful compression fracture in the thoracic or lumbar spine between levels T6 and L5.

Design: Interventional; non-randomized; safety/efficacy; parallel assignment; open label; treatment.

Enrollment: 125



Osteocel(r)Plus in Anterior Cervical Discectomy and Fusion (ACDF)
Osteocel(r)Plus in Anterior Cervical Discectomy and Fusion (ACDF)
http://www.clinicaltrials.gov/ct/show/NCT00942045

Objective: Compare the use of Osteocel(r) Plus in subjects who receive ACDF surgery at one or two levels

Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Enrollment: 175



PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries
PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries
http://www.clinicaltrials.gov/ct/show/NCT 01406405

Objective: Prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.

Design: Observational; case control; prospective.

Enrollment: 240



Percutaneous Diskectomy Spine Jet® x Open Microdiskectomy in Treatment of Lumbar Radiculopathy (PDOP_TLR)
Percutaneous Diskectomy Spine Jet® x Open Microdiskectomy in Treatment of Lumbar Radiculopathy (PDOP_TLR)
http://www.clinicaltrials.gov/ct/show/NCT01367860

Objective: Compare outcomes of patients with contained or extruded disc herniation, with complaints of radiculopathy, concordant with the imaging findings. With treatment by surgical technique or the traditional by SpineJet ®, in order to determine whether percutaneous discectomy with SpineJet ® will produce results comparable to open microdiskectomy.

Design: Interventional; randomized; safety/efficacy; parallel assignment; single blind (outcomes assessor); treatment.

Enrollment: 60



Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating degenerative Disc Disease
Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating degenerative Disc Disease
http://www.clinicaltrials.gov/ct/show/NCT00878579

Objective: Evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one

Design: or two levels from L3-S1 to relieve back pain associated with degenerative disc disease.

Enrollment: Design: Treatment,



Performance of Inductigraft in Spinal Fusion
Performance of Inductigraft in Spinal Fusion
http://www.clinicaltrials.gov/ct/show/NCT01452022

Objective: Evaluate the performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post operation using x-rays and CT scans.

Design: Interventional; non-randomized; safety/efficacy; single group assignment; open label; treatment.

Enrollment: 230



Perioperative Pain Management In Spine Surgery Patients: Part I
Perioperative Pain Management In Spine Surgery Patients: Part I
http://clinicaltrials.gov/ct2/show/NCT01447888?term=spine&rank=38

Objective: The purpose of this study is a comparison of pain management in opioid-tolerant spine surgery patients using a perioperative dosing goal of 150% of patient's baseline oral morphine equivalent (OME), as compared to standard perioperative dosing, which does not currently account for patients' baseline opiate use.

Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label

Enrollment:



Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
http://www.clinicaltrials.gov/ct/show/NCT 01377623

Objective: Examine the effect of DEX on the inflammatory response in major surgery and correlate changes in the concentration of inflammatory mediators with meaningful clinical outcomes.

Design: Observational; cohort; prospective.

Enrollment: 56



Pilot Study to Assess the Safety/Preliminary Effectiveness of Prefix in Subjects with Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery
Pilot Study to Assess the Safety/Preliminary Effectiveness of Prefix in Subjects with Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery
http://www.clinicaltrials.gov/ct/show/NCT00798902

Objective: Evaluate Safety and Preliminary Effectiveness of Prefix as Compared to Autogenous Bone for Spinal Fusion Procedures in Skeletally Mature Subjects with Degenerative Disc Disease at One Level from L2-S1.

Design: Active control; open label; parallel assignment; randomized; safety/efficacy study; treatment.

Enrollment: 22



Pilot Study to Evaluate Feasability of Densi Probe Spine Assessing Bone Strength in Spinal Surgery
Pilot Study to Evaluate Feasability of Densi Probe Spine Assessing Bone Strength in Spinal Surgery
http://www.clinicaltrials.gov/ct/show/NCT01126385

Objective: Investigate the handling and feasibility of the DensiProbe Spine measurement device.

Design: Observational; case-only; prospective.

Enrollment: 30



Postural Balance of the Adult (POSTURADULT)
Postural Balance of the Adult (POSTURADULT)
http://www.clinicaltrials.gov/ct/show/NCT00926432

Objective: Describe the geometrical configuration of the skeleton with regard to gravity line by patients suffering from spinal disorders that may induce postural trouble.

Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Enrollment: 100



Potential Vertebroplasty Use in the Treatment of Vertebral Metastases from Breast and Prostate Cancer
Potential Vertebroplasty Use in the Treatment of Vertebral Metastases from Breast and Prostate Cancer
http://www.clinicaltrials.gov/ct/show/NCT00294151

Objective: Aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone.

Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study.

Enrollment: 30



Pre-operative Embolization in Surgical Treatment of Spinal Metastases
Pre-operative Embolization in Surgical Treatment of Spinal Metastases
http://www.clinicaltrials.gov/ct/show/NCT01365715

Objective: Assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilitate surgical resection in metastatic spine surgery.

Design: Interventional; randomized; efficacy; parallel assignment; single blind (caregiver)

Enrollment: 64



Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine
Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine
http://clinicaltrials.gov/ct2/show/NCT01643174?term=spine&rank=46

Objective: Within defined groups of primary malignant and benign bone and soft tissue spine tumors, what variables (clinical, diagnostic, therapeutic, and/or demographic) are associated with overall survival?

Design: Observational Model: Case-Only Time Perspective: Retrospective

Enrollment:



PRESTIGE Observational Study
PRESTIGE Observational Study
http://www.clinicaltrials.gov/ct/show/NCT00875810

Objective: Collect prospective observational data on the quality of life of patients with the PRESTIGE artificial disc replacement.

Design: Observational; Prospective.

Enrollment: 225



Prestige® Cervical Disc Post-Approval Study
Prestige® Cervical Disc Post-Approval Study
http://www.clinicaltrials.gov/ct/show/NCT00642876

Objective: Assess long-term performance of the PRESTIGE® Cervical Disc in the treatment of patients with cervical degenerative disc disease.

Design: Interventional; randomized; safety/efficacy; parallel assignment; open label; treatment

Enrollment: 541



Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusion
Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusion
http://www.clinicaltrials.gov/ct/show/NCT00555659

Objective: Assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made.

Design: Treatment, Non-Randomized, Open Label, Single Group Assignment.

Enrollment: 200



Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital
Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital
http://clinicaltrials.gov/ct2/show/NCT01278511?term=spine&rank=2

Objective: This study is designed to evaluate the safety, level of performance and level of comfort with the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.

Design: Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic

Enrollment:



Prospective, Multi-Center Clinical Outcomes Study Evaluating the chromos Strip Combined With Bone Marrow Aspirate
Prospective, Multi-Center Clinical Outcomes Study Evaluating the chromos Strip Combined With Bone Marrow Aspirate
http://www.clinicaltrials.gov/ct/show/NCT00943384

Objective: Evaluation of the chronOS Strip, combined with autogenous blood and/or bone marrow aspirate, or autograft such as may be obtained from the posterior spinal elements, is intended to be used in the spine for posterolateral fusion. Following placement into the bony void, chronOS Strip resorbs and is replaced with bone during the healing process.

Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Enrollment: 100



Proton Therapy for Chordomas and/or Chondrosarcomas Outcomes Protocol (CHO1)
Proton Therapy for Chordomas and/or Chondrosarcomas Outcomes Protocol (CHO1)
http://www.clinicaltrials.gov/ct/show/NCT00797602

Objective: Collect information from medical records to see what effects proton beam radiation has on cancer and analyze outcome data on tumor control and normal tissue morbidity.

Design: Interventional; non-randomized; safety/efficacy; single group assignment; open label

Enrollment: 300



Radiation Naive Patients
Radiation Naive Patients
http://www.clinicaltrials.gov/ct/show/NCT01254903

Objective: Learn the feasibility of using a single session of radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural spinal cord compression.

Design: Non-Randomized;Safety/Efficacy Study; Single Group Assignment; Open Label; Treatment

Enrollment: 36



Radiation Therapy in Treating Patients with Malignant Spinal Cord Compression Who Were Previously Treated With Radiation Therapy
Radiation Therapy in Treating Patients with Malignant Spinal Cord Compression Who Were Previously Treated With Radiation Therapy
http://www.clinicaltrials.gov/ct/show/NCT00974168

Objective: Study radiation therapy in treating patients with malignant spinal cord compression.

Design: Treatment, Open Label

Enrollment: 40



Radiation Therapy in Treating Patients with Metastatic Spinal Cord Compression
Radiation Therapy in Treating Patients with Metastatic Spinal Cord Compression
http://www.clinicaltrials.gov/ct/show/NCT00727584

Objective: Compare two radiation therapy regimes (single fraction vs. multi fraction) to see how well they work in treating patients with metastatic spinal cord compression.

Design: Treatment; randomized.

Enrollment: 100



Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)
Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)
http://www.clinicaltrials.gov/ct/show/NCT01293981

Objective: Assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody fusion.

Design: Observational; cohort; prospective.

Enrollment: 150



Reorganization of brain Functions in Patients with Spinal Cord Compression using fMRI
Reorganization of brain Functions in Patients with Spinal Cord Compression using fMRI
http://www.clinicaltrials.gov/ct/show/NCT00447343

Objective: Use fMRI to investigate the relationship between clinical symptoms and recovery of brain activation following surgery.

Design: Screening; longitudinal; defined population; prospective study.

Enrollment: 35



Response Shift in Patient Expectations and Functional Outcome
Response Shift in Patient Expectations and Functional Outcome
http://www.clinicaltrials.gov/ct/show/NCT00289393

Objective: Evaluate the results of elective lumbar spinal surgery as it relates to shifting patient expectations for outcome. Patients undergoing elective posterior spinal surgery for degenerative conditions of the spine at SWCHSC will be evaluated.

Design: Longitudinal, Defined Population, Retrospective/Prospective Study

Enrollment: Not listed



Robotic-Assisted Surgery in Treating Patients With Spine Tumors
Robotic-Assisted Surgery in Treating Patients With Spine Tumors
http://clinicaltrials.gov/ct2/show/NCT01345903?term=spine&rank=96

Objective: This pilot clinical trial studies robotic-assisted surgery in treating patients with spine tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may have fewer side effects and improve recovery

Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label

Enrollment:



Safety and Efficacy of the Transdiscal System versus Medical Management in Treating Chronic Discogenic Low Back Pain
Safety and Efficacy of the Transdiscal System versus Medical Management in Treating Chronic Discogenic Low Back Pain
http://www.clinicaltrials.gov/ct/show/NCT01263054

Objective: Evaluate Discal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure.

Design: Interventional; randomized; safety/efficacy; parallel assignment; open label; treatment.

Enrollment: 136



Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion
Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion
http://www.clinicaltrials.gov/ct/show/NCT00810212

Objective: Evaluate safety and efficacy of NeoFusetm in subjects with a diagnosis of degenerative disc disease in 1 or 2 adjacent vertebral levels between L1 and L2 and undergoing posterolateral lumbar fusion.

Design: active control; parallel assignment; randomized; safety study; single blind (outcomes assessment); treatment.

Enrollment: 120



Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion
Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion
http://www.clinicaltrials.gov/ct/show/NCT01106417

Objective: Evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level anterior cervical discectomy and fusion with Anterior Cervical Plate Fixation.

Design: Interventional; randomized; safety/efficacy; parallel assignment; single blind (outcome assessor); treatment.

Enrollment: Enrollment: 12



Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine
Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine
http://www.clinicaltrials.gov/ct/show/NCT01323543

Objective: Evaluate the safety and efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure.

Design: Interventional; safety/efficacy; single group assignment; open label; treatment

Enrollment: 40



Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
http://www.clinicaltrials.gov/ct/show/NCT00996073

Objective: Evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1. All subjects in this study will undergo interbody fusion via Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) procedures with Food and Drug Administration (FDA) approved/cleared supplemental posterior instrumentation.

Design: Interventional; randomized; active control safety/efficacy; parallel assignment; single blind; treatment.

Enrollment: Enrollment: 24



Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy
http://www.clinicaltrials.gov/ct/show/NCT01097486

Objective: Evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level anterior cervical discectomy and fusion with anterior cervical plate fixation.

Design: Interventional; randomized; active control; safety/efficacy; parallel assignment; single blind (outcome assessor); treatment.

Enrollment: Enrollment: 24



Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
http://www.clinicaltrials.gov/ct/show/NCT00344890

Objective: compare the safety and efficacy of Preservon(TM) treated allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or myelopathy.

Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Enrollment: 120



Salient Aquamantys Spine Trial
Salient Aquamantys Spine Trial
http://www.clinicaltrials.gov/ct/show/NCT01331499

Objective: Assess the effectiveness of Aquamantys in reducing peri-operative blood loss compared with standard electrocautery

Design: Interventional; randomized; efficacy; parallel assignment; open label; health services research

Enrollment: 128



Scoliosis Surgery Using the PASS® LP System
Scoliosis Surgery Using the PASS® LP System
http://www.clinicaltrials.gov/ct/show/NCT01019109

Objective: Find out the outcomes of using the PASS LP System to correct idiopathic scoliosis.

Design: Interventional; non-randomized; safety/efficacy; single group assignment; open label; treatment.

Enrollment: 120



Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine
Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine
http://clinicaltrials.gov/ct2/show/NCT01318720?term=spine&rank=32

Objective: Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on techniques for the treatment of neck pain is an intervention commonly implemented in clinical practice. Recently researchers and clinicians have implemented manual therapy techniques to the thoracic spine (midback) to treat patients with neck pain. To date no studies have examined the short-term combined effects of thoracic spine manual therapy and cervical spine manual therapy in the treatment of patients with mechanical neck pain. The purpose this study is to assess the combined effects of thoracic spine thrust manipulation with cervical spine non-thrust manipulation in patients with neck pain.

Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

Enrollment:



Side Effects of Radiation Therapy in Young patients with CNS Tumors
Side Effects of Radiation Therapy in Young patients with CNS Tumors
http://www.clinicaltrials.gov/ct/show/NCT00401037

Objective: To study the side effects of radiation therapy in young patients with CNS tumors.

Design: Observational.

Enrollment: 150



Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression
Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression
http://www.clinicaltrials.gov/ct/show/NCT01256554

Objective: Learn the feasibility of using a single session of radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural spinal cord compression.

Design: Interventional; non-randomized; safety/efficacy; single group assignment; open label; treatment.

Enrollment: Enrollment: 36



Solas® Spinal Surgery Registry
Solas® Spinal Surgery Registry
http://www.clinicaltrials.gov/ct/show/NCT01372592

Objective: A prospective multi-center observational data collection initiative, to capture clinical and radiographic outcomes in candidates for spine surgery with degenerative, deformity, and traumatic pathologies

Design: Observational; cohort; prospective

Enrollment: 10,000



Spinal Abnormalities in Neurofibromatosis -Type I
Spinal Abnormalities in Neurofibromatosis -Type I
http://www.clinicaltrials.gov/ct/show/NCT00844129

Objective: Determine the Incidence and Clinical History of Neurofibromatosis Type I-related spinal abnormalities.

Design: Observational, cohort, prospective.

Enrollment: over 4 years; number



Spinal Cord Stimulation to Restore Cough
Spinal Cord Stimulation to Restore Cough
http://www.clinicaltrials.gov/ct/show/NCT00116337

Objective: Determine efficacy of spinal cord stimulator to produce an effective cough in patients with spinal cord injuries.

Design: Open label; safety/efficacy study; single group assignment; treatment; uncontrolled.

Enrollment: 18



Spinal Cord Stimulation with Precision® SCS System versus Reoperation for Failed Back Surgery Syndrome (Evidence)
Spinal Cord Stimulation with Precision® SCS System versus Reoperation for Failed Back Surgery Syndrome (Evidence)
http://www.clinicaltrials.gov/ct/show/NCT01036529

Objective: Randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS).

Design: Interventional; randomized; efficacy; single group assignment; open label; treatment.

Enrollment: 132



Spinal met_radiosurgery/SBRT Study
Spinal met_radiosurgery/SBRT Study
http://clinicaltrials.gov/ct2/show/NCT01231061?term=spine&rank=74

Objective: Demonstrate the technical feasibility of treating spine metastases with image-guided radiosurgery/SBRT

Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label

Enrollment:



Spine Reference Parameters on EOS Imaging
Spine Reference Parameters on EOS Imaging
http://clinicaltrials.gov/ct2/show/NCT01406743?term=spine&rank=5

Objective: The lumbar pain caring consists from a 3D reconstruction of the spine obtained to scan or radiography, determining the lumbar pain cause and gravity, to propose a conservative treatment in first intention or a adapted spine surgery in first or second intention (Fritzell and al ., on 2001). The analysis and the correction of postural disorders pass inevitably by a good knowledge of the not pathological posture. The validation of the acquisition 2D / 3D reconstruction by EOS ™ technology demonstrated its interest for the diagnosis and the lumbar pain caring. However, the EOS technology ™ is recent and few data were acquired with this technology for healthy population. So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of the standing skeleton in position (to an asymptomatic adult population), by displaying the gravity constraints on the joints, and the compensation phenomena in normal situation. This functional information for a given age bracket would allow to propose to the patients with lumbar pain, adapted interventions to the gravity constraints considering the skeleton evolution for age bracket.

Design: Observational Model: Cohort Time Perspective: Prospective

Enrollment:



Spine Research with Roentgen Stereophotogrammetric Analysis (Spine RSA)
Spine Research with Roentgen Stereophotogrammetric Analysis (Spine RSA)
http://www.clinicaltrials.gov/ct/show/NCT00493558

Objective: Gather information on effectiveness of a new spine implant for patients who require spinal fusion surgery.

Design: Treatment; open label; uncontrolled; single group assignment; efficacy study.

Enrollment: 25



SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis
SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis
http://www.clinicaltrials.gov/ct/show/NCT00869882

Objective: This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion.

Design: Allocation: Randomized Control: Active Control; Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment

Enrollment: 70



Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
http://www.clinicaltrials.gov/ct/show/NCT01485289

Objective: Complete the collection of clinical data on subjects enrolled in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the now defunct Applied Spine Technologies Inc.

Design: Observational; case-only; prospective

Enrollment: 25



Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metasis
Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metasis
http://www.clinicaltrials.gov/ct/show/NCT00855803

Objective: To study how well giving stereotactic body radiation therapy together with vertebroplasty works in treating patients with localized spinal metastasis.

Design: Treatment, Open Label

Enrollment: 42



Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases (Spine SBRT)
Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases (Spine SBRT)
http://www.clinicaltrials.gov/ct/show/NCT01290562

Objective: Proposes to treat patients with a uniform spine SBRT approach, and collect prospective outcome data as a basis for future randomized trial design.

Design: Interventional; non-randomized; efficacy; single group assignment; open label; treatment.

Enrollment: 90



Stereotactic Body Radiotherapy for Spine Tumors
Stereotactic Body Radiotherapy for Spine Tumors
http://www.clinicaltrials.gov/ct/show/NCT01347307

Objective: Evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.

Design: Interventional; non-randomized; safety/efficacy; single group assignment; open label; treatment

Enrollment: 50



Stereotactic Radiosurgery
Stereotactic Radiosurgery
http://www.clinicaltrials.gov/ct/show/NCT00593320

Objective: Evaluate the most effective radiation dose for spine metastases.

Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study.

Enrollment: 72



Strategy for Maintaining Partial Neuromuscular Blockade Adequate for Motor Evoked Potential During Neurosurgery
Strategy for Maintaining Partial Neuromuscular Blockade Adequate for Motor Evoked Potential During Neurosurgery
http://www.clinicaltrials.gov/ct/show/NCT01388868

Objective: Find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module.

Design: Interventional; randomized; safety study; parallel assignment; single blind (outcomes assessor); treatment

Enrollment: 90



Study Evaluating the Safety and Effectiveness of the FLEXUS™ Interspinous Spacer
Study Evaluating the Safety and Effectiveness of the FLEXUS™ Interspinous Spacer
http://www.clinicaltrials.gov/ct/show/NCT01156675

Objective: Evaluate safety and efficacy of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® spacer for the treatment of patients suffering from spinal stenosis at one or two contiguous levels.

Design: Interventional; randomized; active control; safety/efficacy study; parallel assignment; single blind; treatment.

Enrollment: 500



Study of 3 Doses of NeoFuse Combined With Mastergraft Granules in Subjects Requiring Posterolateral Lumbar fusion (PLF)
Study of 3 Doses of NeoFuse Combined With Mastergraft Granules in Subjects Requiring Posterolateral Lumbar fusion (PLF)
http://www.clinicaltrials.gov/ct/show/NCT00549913

Objective: 1st-in-human dose escalation study to evaluate feasibility, safety and tolerability of 3 different doses of NeoFuse when combined with MasterGraft.

Design: Treatment; randomized; open label; parallel assignment; safety study.

Enrollment: 40



Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (MILD®) in Patients With Symptomatic Lumbar Central Canal Stenosis
Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (MILD®) in Patients With Symptomatic Lumbar Central Canal Stenosis
http://www.clinicaltrials.gov/ct/show/NCT00995371

Objective: Assess the clinical application and outcomes with MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.

Design: Single-center, randomized, prospective, double-blind clinical study

Enrollment: 40



Study of MILD(r) Devices in Patients with Symptomatic Lumbar Spinal Stenosis
Study of MILD(r) Devices in Patients with Symptomatic Lumbar Spinal Stenosis
http://www.clinicaltrials.gov/ct/show/NCT00956631

Objective: Assess the clinical application and outcomes of Minimally Invasive Lumbar Decompression with the MILD(r) devices in patients with symptomatic lumbar spinal stenosis.

Design: Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Enrollment: 75



Study of the Safety and Effectiveness DIAM™ Spinal Stabilization System vs. Conservative Care
Study of the Safety and Effectiveness DIAM™ Spinal Stabilization System vs. Conservative Care
http://www.clinicaltrials.gov/ct/show/NCT00456378

Objective: Establish the safety and effectiveness of the DIAM™ Spinal Stabilization System in the treatment of moderate single-level lumbar degenerative disc disease.

Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study.

Enrollment: 306



Study on the Treatment of Degenerative lumbar Spine Stenosis with a Percutaneous Interspinous Implant
Study on the Treatment of Degenerative lumbar Spine Stenosis with a Percutaneous Interspinous Implant
http://www.clinicaltrials.gov/ct/show/NCT01057641

Objective: Study to investigate the safety and the benefit of a minimally invasive percutaneous IPD-device in comparison with the best non-surgical operative treatment of lumbar spinal stenosis.

Design: Interventional; randomized; efficacy study; parallel assignment; open label; treatment

Enrollment: 22



Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant
Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant
http://clinicaltrials.gov/ct2/show/NCT01057641?term=spine&rank=83

Objective: The study is intended as a randomised, monocentre study to investigate the safety and the benefit of a minimally invasive percutaneous IPD-device in comparison with the best non-surgical operative treatment of lumbar spinal stenosis.

Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label

Enrollment:



Surgery versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
Surgery versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
http://www.clinicaltrials.gov/ct/show/NCT01335646

Objective: Determine if surgery is superior to non-operative care for sciatica caused by a lumbar disc herniation.

Design: Interventional; randomized; parallel assignment; single blind (subject);treatment

Enrollment: 140



Surgical Management of Spinal Cord Injuries In Neck
Surgical Management of Spinal Cord Injuries In Neck
http://www.clinicaltrials.gov/ct/show/NCT00475748

Objective: In acute traumatic central cord syndrome, compare surgical decompression of the spinal cord within 5 days with decompression 6 weeks following injury.

Design: Single center prospective randomized study.

Enrollment: 30



Surgical Treatment of Cervical Spondylotic Myelopathy
Surgical Treatment of Cervical Spondylotic Myelopathy
http://www.clinicaltrials.gov/ct/show/NCT00565734

Objective: Compare anterior and posterior surgical approach in treatment of CSM and to compare variations in treatment and outcomes of CSM worldwide.

Design: Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study.

Enrollment: 375



Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression (MESCC)
Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression (MESCC)
http://www.clinicaltrials.gov/ct/show/NCT00634426

Objective: Evaluate differences in pain relief, neurological function, quality of life and survival in patients with metastatic epidural spinal cord compression who are managed with a combo of surgery and radiotherapy versus radiotherapy alone.

Design: Cohort; prospective

Enrollment: 432



Synvisc Injections for Lumbar Facet Joint Pain
Synvisc Injections for Lumbar Facet Joint Pain
http://www.clinicaltrials.gov/ct/show/NCT00325845

Objective: Evaluate the safety and efficacy of viscosupplementation in treating symptomatic lumbar facet joint arthropathy.

Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.

Enrollment: 15



Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Disc
Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Disc
http://www.clinicaltrials.gov/ct/show/NCT01429363

Objective: Aims to prove the hypothesis that Targeted Disc Decompression (TDD) reduces the pain in patients suffering from radicular leg pain secondary to a contained focal disc protrusion (Lumboradicular Syndrome). Secondary objective will be to prove that the treatment Group will have less disability and better quality of life.

Design: Interventional; non-randomized; efficacy study; single group assignment; open label; treatment

Enrollment: 20



The CSM Trial: A Multicenter Study Comparing ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy
The CSM Trial: A Multicenter Study Comparing ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy
http://www.clinicaltrials.gov/ct/show/NCT00506558

Objective: To determine the optimal surgical approach (ventral versus dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM).

Design: Treatment, non-randomized, open label, active control, parallel assignment, safety/efficacy study

Enrollment: 100



The Effect of Prolonged Postoperative Antibiotics Administration on Rate of Infection in Patients Undergoing Posterior Spine Surgery Requiring a Hemovac Drain
The Effect of Prolonged Postoperative Antibiotics Administration on Rate of Infection in Patients Undergoing Posterior Spine Surgery Requiring a Hemovac Drain
http://clinicaltrials.gov/ct2/show/NCT01458223?term=spine&rank=34

Objective: The proposed study will compare two patient populations who will receive various lengths of post-operative antibiotics. One will receive only 24 hours worth, and the other will receive antibiotics for 72 hours after surgery and the rate of complicated infection compared between the two.

Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention

Enrollment:



The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
http://www.clinicaltrials.gov/ct/show/NCT01067014

Objective: Evaluate the safety and effectiveness of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.

Design: Observational; case-only; prospective

Enrollment: 75



The Kiva® System as a Vertebral Augmentation Treatment
The Kiva® System as a Vertebral Augmentation Treatment
http://www.clinicaltrials.gov/ct/show/NCT01123572

Objective: Evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine.

Design: Interventional; randomized; safety/efficacy; parallel assignment; open label; treatment

Enrollment: 425



The Value of Traction in the Treatment of Cervical Radiculopathy
The Value of Traction in the Treatment of Cervical Radiculopathy
http://www.clinicaltrials.gov/ct/show/NCT00979108

Objective: Determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with neck and arm pain.

Design: Interventional; randomized; active study; control; parallel assignment; single blind (investigator); open ; treatment

Enrollment: 192



Thoracic Manipulation in Patients With Cervical Radiculopathy
Thoracic Manipulation in Patients With Cervical Radiculopathy
http://clinicaltrials.gov/ct2/show/NCT01495728?term=spine&rank=53

Objective: The group of Cervical Radiculopathy patients receiving thoracic thrust manipulation will demonstrate immediate and short term significant clinically important changes in outcomes when compared to the sham manipulation group.

Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment

Enrollment:



Total Facet Arthroplasty System (TFAS) Clinical Trial
Total Facet Arthroplasty System (TFAS) Clinical Trial
http://www.clinicaltrials.gov/ct/show/NCT00418197

Objective: TFAS is a non-fusion spinal implant for treatment of moderate to severe spinal stenosis as an alternative to rigid spinal fusion.

Design: Treatment, randomized, open label, active control, parallel assignment, safety/efficacy study.

Enrollment: 450



Tranexamic Acid (TXA) Versus Epsilon Aminoceproic Acid (EACA) Versus Placebo for Spine Surgery
Tranexamic Acid (TXA) Versus Epsilon Aminoceproic Acid (EACA) Versus Placebo for Spine Surgery
http://www.clinicaltrials.gov/ct/show/NCT00958581

Objective: Compare TXA with both EACA and placebo in reducing blood loss for corrective spinal surgery.

Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Enrollment: 390



Treatment of Cervical Radiculopathy with Arthroplasty Compared with Discectomy and Fusion and Cage (ACDF)
Treatment of Cervical Radiculopathy with Arthroplasty Compared with Discectomy and Fusion and Cage (ACDF)
http://www.clinicaltrials.gov/ct/show/NCT00735176

Objective: Compare cervical arthroplasty with cervical discectomy and fusion in treatment of cervical radiculopathy.

Design: Active control; efficacy study; parallel assignment; randomized; single blind(subject); treatment.

Enrollment: 146



Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-invasive Decompression to XSTOP (LSSS)
Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-invasive Decompression to XSTOP (LSSS)
http://www.clinicaltrials.gov/ct/show/NCT00546949

Objective: Compare two operation methods on lumbar spinal stenosis.

Design: Treatment; randomized; open label; parallel assignment; safety/efficacy study.

Enrollment: 180



Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
http://www.clinicaltrials.gov/ct/show/NCT01011816

Objective: Establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another group receiving a preservative-free normal saline control delivered with the Biostat Delivery.

Design: Interventional; randomized; placebo controlled; safety/efficacy; parallel assignment; double blind (subject/outcome assessor); treatment.

Enrollment: Enrollment: 260



Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
http://www.clinicaltrials.gov/ct/show/NCT00931515

Objective: Demonstrate non-inferiority compared to ProDisc.

Design: Interventional; randomized; active control; safety/efficacy study; single group assignment; single blind (subject); treatment

Enrollment: 400



Trinity Evolution in Anterior Cervical Discectomy and Fusion (ACDF)
Trinity Evolution in Anterior Cervical Discectomy and Fusion (ACDF)
http://www.clinicaltrials.gov/ct/show/NCT00951938

Objective: Utilize Trinity Evolution in conjunction with an interbody spacer and supplemental anterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion.

Design: Case-Only, Prospective

Enrollment: 200



TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
http://www.clinicaltrials.gov/ct/show/NCT01198470

Objective: Evaluate the safety and effectiveness of the TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc Disease (DDD) at one level from L1 to S1.

Design: Interventional; non-randomized; safety/efficacy; single group assignment; open label; treatment.

Enrollment: Enrollment: 50



Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
http://www.clinicaltrials.gov/ct/show/NCT01292252

Objective: Determine the effects of 12 weeks of daily treatment with teriparatide on spine fusion in adult patients who are undergoing multi-level posterolateral spine fusion surgery for degenerative conditions of the lumbar spine.

Design: Interventional; randomized; efficacy; parallel assignment; open label; treatment

Enrollment: 90



VEPTR Implantation to Treat Children with Early Onset Scoliosis Without Rib Abnormalities
VEPTR Implantation to Treat Children with Early Onset Scoliosis Without Rib Abnormalities
http://www.clinicaltrials.gov/ct/show/NCT00689533

Objective: Evaluate the use of unilateral or bilateral VEPTR devices, with or without expansion thoracoplasty, for preventing further progression of the Cobb angle, allowing for spinal growth and improving pulmonary function in the treatment of children with progressive scoliosis without rib abnormalities.

Design: Observational; Cohort; Prospective

Enrollment: 250



Vertos Mild® Patient Outcomes 02
Vertos Mild® Patient Outcomes 02
http://www.clinicaltrials.gov/ct/show/NCT01082159

Objective: Patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.

Design: Multi-center;prospective; historical control; safety/efficacy study; single group assignment; open label; treatment

Enrollment: 50



Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery
Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery
http://www.clinicaltrials.gov/ct/show/NCT01017055

Objective: Evaluate voice and swallowing outcomes post operatively.

Design: Observational; cohort; prospective.

Enrollment: Enrollment: 50



Vorinostat and Temozolomide in Treating Young Patients with Relapsed or Refractory Primary Brain Tumors or Spinal Cord Tumors
Vorinostat and Temozolomide in Treating Young Patients with Relapsed or Refractory Primary Brain Tumors or Spinal Cord Tumors
http://www.clinicaltrials.gov/ct/show/NCT01076530

Objective: Phase I trial to study side effects and best dose of Vorinostat when given together with Temozolomide in treating young patients with relapsed or refractory primary brain tumors or spinal cord tumors.

Design: Interventional; open label; treatment.

Enrollment: 27



XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
http://www.clinicaltrials.gov/ct/show/NCT00927238

Objective: Evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.

Design: Interventional; non-randomized; safety/efficacy; single group assignment; open label; treatment.

Enrollment: Enrollment: 300



XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis
XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis
http://www.clinicaltrials.gov/ct/show/NCT01024699

Objective: Determine differences in the XLIF and TLIF procedures with respect to perioperative variables in adult patients with low-grade symptomatic spondylolisthesis.

Design: Observational; cohort; prospective

Enrollment: 110



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