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AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves
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Saturday, July 31, 2010 |
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Clinical Trials
Grant Information and CoursesSpine Clinical Trial Proposal and Fellowship Award Information
Spine Clinical Trial Proposal - $500Spine Clinical Fellowship Award - $50,000
DEADLINE FOR SUBMISSION: January 1, 2010
The AANS/CNS Section on Disorders of the Spine and Peripheral Nerves is pleased to announce the creation of a clinical trials fellowship award to promote clinical trials in spine. Neurosurgical residents/ fellows/ junior faculty are eligible to submit proposals ($500). Only junior faculty are eligible for the Fellowship Award ($ 50,000). The objective of this Fellowship is to foster the spirit of team-building necessary for executing multi-center studies, which are critically needed in neurosurgery in general, and spinal surgery in particular.
Procedure for applying for the award and more information.
Please send all proposals and questions to Zoher Ghogawala, MD.
A Pilot Study to Explore Serum and Imagery Biomarkers in Patients With Spinal Cord Compression
A Pilot Study to Explore Serum and Imagery Biomarkers in Patients With Spinal Cord Compression
http://www.clinicaltrials.gov/ct/show/NCT00928382
Objective: compare patients with cancer of the spinal vertebrae with and without symptoms of spinal cord compression by looking at markers in the blood and changes on novel magnetic resonance imaging (MRI) techniques that might allow researchers to predict who will experience spinal cord compression before they actually begin to have symptoms.
Design: Observational; prospective.
Enrollment: 65
http://www.clinicaltrials.gov/ct/show/NCT00928382
Objective: compare patients with cancer of the spinal vertebrae with and without symptoms of spinal cord compression by looking at markers in the blood and changes on novel magnetic resonance imaging (MRI) techniques that might allow researchers to predict who will experience spinal cord compression before they actually begin to have symptoms.
Design: Observational; prospective.
Enrollment: 65
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
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
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
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
Acute Safety, Tolerability, Feasability and Pharmakokinetics of Intrathecal Administered AT1355 in Patients with Acute Spinal Cord Injury
Acute Safety, Tolerability, Feasability and Pharmakokinetics of Intrathecal Administered AT1355 in Patients with Acute Spinal Cord Injury
http://www.clinicaltrials.gov/ct/show/NCT00406016
Objective: Evaluate acute safety, tolerability, feasibility and pharmacokinetics of 5 dose regimens of AT1355 in acute spinal cord injury.
Design: Non-randomized, open label, safety study,single group assignment, treatment, uncontrolled.
Enrollment: 35
http://www.clinicaltrials.gov/ct/show/NCT00406016
Objective: Evaluate acute safety, tolerability, feasibility and pharmacokinetics of 5 dose regimens of AT1355 in acute spinal cord injury.
Design: Non-randomized, open label, safety study,single group assignment, treatment, uncontrolled.
Enrollment: 35
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
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
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
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
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
Benefits of Applying Neuroprosthesis to Improve Grasping and Reaching in Spinal Cord Injury Patients
Benefits of Applying Neuroprosthesis to Improve Grasping and Reaching in Spinal Cord Injury Patients
http://www.clinicaltrials.gov/ct/show/NCT00221117
Objective: Evaluate effectiveness and long-term benefits of applying functional electrical stimulation during early rehabilitation to improve grasping function in patients who have suffered a spinal cord injury.
Design: Active control, efficacy study, open label, parallel assignment, randomized, Treatment.
Enrollment: 40
http://www.clinicaltrials.gov/ct/show/NCT00221117
Objective: Evaluate effectiveness and long-term benefits of applying functional electrical stimulation during early rehabilitation to improve grasping function in patients who have suffered a spinal cord injury.
Design: Active control, efficacy study, open label, parallel assignment, randomized, Treatment.
Enrollment: 40
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
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
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
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 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
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
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
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 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
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
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
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
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
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
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
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
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
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
Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis
Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis
http://www.clinicaltrials.gov/ct/show/NCT00508066
Objective: Evaluate effects of continuous local anesthetic during an immediate post-op period recovery of patients undergoing spinal fusion surgery for congenital or idiopathic scoliosis.
Design: double blind; parallel assignment; placebo control; randomized; safety/efficacy study; treatment.
Enrollment: 60
http://www.clinicaltrials.gov/ct/show/NCT00508066
Objective: Evaluate effects of continuous local anesthetic during an immediate post-op period recovery of patients undergoing spinal fusion surgery for congenital or idiopathic scoliosis.
Design: double blind; parallel assignment; placebo control; randomized; safety/efficacy study; treatment.
Enrollment: 60
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
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
DuraGen Plus Adhesion Barrier for Use in Spinal Surgery
DuraGen Plus Adhesion Barrier for Use in Spinal Surgery
http://www.clinicaltrials.gov/ct/show/NCT00387829
Objective: Evaluate safety and effectiveness of DuraGen Plus adhesion Barrier Matrix in spinal fusion to reduce fibrosis and radicular pain.
Design: Treatment, Randomized, Double-Blind, Active Control, Safety/Efficacy Study
Enrollment: 500
http://www.clinicaltrials.gov/ct/show/NCT00387829
Objective: Evaluate safety and effectiveness of DuraGen Plus adhesion Barrier Matrix in spinal fusion to reduce fibrosis and radicular pain.
Design: Treatment, Randomized, Double-Blind, Active Control, Safety/Efficacy Study
Enrollment: 500
Dynamic Stabilization for Lumbar Spine Stenosis with Stabilmax NZ® Dynamic Spine Stabilization System
Dynamic Stabilization for Lumbar Spine Stenosis with Stabilmax NZ® Dynamic Spine Stabilization System
http://www.clinicaltrials.gov/ct/show/NCT00479544
Objective: Assess whether the Stabilimax NZ™ is at least as safe and effective as control therapy of fusion in patients receiving surgical decompression for the treatment of symptomatic spinal stenosis at one or two contiguous levels from L1-S1.
Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/efficacy Study.
Enrollment: 480
http://www.clinicaltrials.gov/ct/show/NCT00479544
Objective: Assess whether the Stabilimax NZ™ is at least as safe and effective as control therapy of fusion in patients receiving surgical decompression for the treatment of symptomatic spinal stenosis at one or two contiguous levels from L1-S1.
Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/efficacy Study.
Enrollment: 480
Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain
Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain
http://www.clinicaltrials.gov/ct/show/NCT00370994
Objective: Demonstrate clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic neurolysis compared to patients randomized to control group.
Design: Active control; double-blind; parallel assignment; randomized; safety/efficacy study; treatment.
Enrollment: 120
http://www.clinicaltrials.gov/ct/show/NCT00370994
Objective: Demonstrate clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic neurolysis compared to patients randomized to control group.
Design: Active control; double-blind; parallel assignment; randomized; safety/efficacy study; treatment.
Enrollment: 120
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
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 Ropivacaine Continuous Wound Instillation Versus Single Shot after Spine Fusion Surgery
Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot after Spine Fusion Surgery
http://www.clinicaltrials.gov/ct/show/NCT00823576
Objective: Compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an infiltration "single shot" of local analgesic (Ropivaca•ne), one receiving a single shot infiltration and a continuous infiltration of Ropivicaine during 48 hours.
Design: Dose comparison; efficacy study; open label; parallel assignment; randomized; treatment.
Enrollment: 64
http://www.clinicaltrials.gov/ct/show/NCT00823576
Objective: Compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an infiltration "single shot" of local analgesic (Ropivaca•ne), one receiving a single shot infiltration and a continuous infiltration of Ropivicaine during 48 hours.
Design: Dose comparison; efficacy study; open label; parallel assignment; randomized; treatment.
Enrollment: 64
Establishing the Physiology of Syringomyelia
Establishing the Physiology of Syringomyelia
http://www.clinicaltrials.gov/ct/show/NCT00001327
Objective: Learn more about how the CSF pressure and flow contribute to the progression of syringomyelia
Design: Observational
Enrollment: 120
http://www.clinicaltrials.gov/ct/show/NCT00001327
Objective: Learn more about how the CSF pressure and flow contribute to the progression of syringomyelia
Design: Observational
Enrollment: 120
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
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
Establishment of Optimal Transfusion Threshold During Spine Surgery
Establishment of Optimal Transfusion Threshold During Spine Surgery
http://www.clinicaltrials.gov/ct/show/NCT00967109
Objective: Determine whether a higher threshold for transfusion with red blood cells improves the tissue oxygenation.
Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Enrollment: 10
http://www.clinicaltrials.gov/ct/show/NCT00967109
Objective: Determine whether a higher threshold for transfusion with red blood cells improves the tissue oxygenation.
Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Enrollment: 10
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
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 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
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 Prosthetic Disc Replacement (EVA)
Evaluation of the Prosthetic Disc Replacement (EVA)
http://www.clinicaltrials.gov/ct/show/NCT00640029
Objective: Analyze results of the arthroplasty in terms of functional effects, quality of life and anatomical results.
Design: Treatment; randomized; open label; active control; parallel assignment; efficacy study.
Enrollment: none given
http://www.clinicaltrials.gov/ct/show/NCT00640029
Objective: Analyze results of the arthroplasty in terms of functional effects, quality of life and anatomical results.
Design: Treatment; randomized; open label; active control; parallel assignment; efficacy study.
Enrollment: none given
Feasability Study of Balloon Kyphoplasty in Traumatic Vetebral fractures Needing Surgical Fixation (TRAUMA+3B1C1)
Feasability Study of Balloon Kyphoplasty in Traumatic Vetebral fractures Needing Surgical Fixation (TRAUMA+3B1C1)
http://www.clinicaltrials.gov/ct/show/NCT00749229
Objective: Show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.
Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.
Enrollment: 50
http://www.clinicaltrials.gov/ct/show/NCT00749229
Objective: Show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.
Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.
Enrollment: 50
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
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
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
http://www.clinicaltrials.gov/ct/show/NCT00736398
Objective: Assess clinical outcomes in patients who undergo spinal fusion.
Design: Cohort; prospective
Enrollment: 50
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
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
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
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
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
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
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
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
Intra-Operative Dural Brachytherapy with Yttrium-90 Plaque Applicators
Intra-Operative Dural Brachytherapy with Yttrium-90 Plaque Applicators
http://www.clinicaltrials.gov/ct/show/NCT00706485
Objective: Determine the feasibility of the Y-90 plaque applicator.
Design: Treatment; non-randomized; open label; parallel assignment; efficacy study.
Enrollment: 10
http://www.clinicaltrials.gov/ct/show/NCT00706485
Objective: Determine the feasibility of the Y-90 plaque applicator.
Design: Treatment; non-randomized; open label; parallel assignment; efficacy study.
Enrollment: 10
Intrathecal Enzyme Repalcement Therapy for Spinal Cord Compression in Mucopolysaccharidosis (MPS I)
Intrathecal Enzyme Repalcement Therapy for Spinal Cord Compression in Mucopolysaccharidosis (MPS I)
http://www.clinicaltrials.gov/ct/show/NCT00215527
Objective: Study use of enzyme replacement therapy into the spinal fluid for treatment of spinal cord compression in the Hurler-Scheic and Schei forms of Mucopolysaccharidosis I.
Design: Treatment; non-randomized; open label; uncontrolled; single group assignment; safety/efficacy study.
Enrollment: 10
http://www.clinicaltrials.gov/ct/show/NCT00215527
Objective: Study use of enzyme replacement therapy into the spinal fluid for treatment of spinal cord compression in the Hurler-Scheic and Schei forms of Mucopolysaccharidosis I.
Design: Treatment; non-randomized; open label; uncontrolled; single group assignment; safety/efficacy study.
Enrollment: 10
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
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
KAVIAR Study-Kyphoplasty and Vertebroplasty in the Augmentation and Restoration of Vertebral Body Compression Fractures
KAVIAR Study-Kyphoplasty and Vertebroplasty in the Augmentation and Restoration of Vertebral Body Compression Fractures
http://www.clinicaltrials.gov/ct/show/NCT00323609
Objective: Patients with compression fractures randomized to kyphoplasty or vertebroplasty for comparison.
Design: Treatment, randomized, open label, active control, parallel assignment, safety/efficacy study.
Enrollment: 1,234
http://www.clinicaltrials.gov/ct/show/NCT00323609
Objective: Patients with compression fractures randomized to kyphoplasty or vertebroplasty for comparison.
Design: Treatment, randomized, open label, active control, parallel assignment, safety/efficacy study.
Enrollment: 1,234
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
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
Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated with XSTOP®
Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated with XSTOP®
http://www.clinicaltrials.gov/ct/show/NCT00534092
Objective: Supplement safety and effectiveness data for XSTOP® device.
Design: Screening; longitudinal; defined population; retrospective/prospective study.
Enrollment: 75
http://www.clinicaltrials.gov/ct/show/NCT00534092
Objective: Supplement safety and effectiveness data for XSTOP® device.
Design: Screening; longitudinal; defined population; retrospective/prospective study.
Enrollment: 75
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
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
http://www.clinicaltrials.gov/ct/show/NCT00758719
Objective: Evaluate effectiveness of the Biomet Lumbar Spinal Fusion System
Design: Prospective
Enrollment: 480
Lumbar Stenosis Outcomes Research (LUSTOR)
Lumbar Stenosis Outcomes Research (LUSTOR)
http://www.clinicaltrials.gov/ct/show/NCT00638443
Objective: Determine efficacy of pregabalin in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients with neurogenic intermittent claudication.
Design: cohort;prospective.
Enrollment: 37
http://www.clinicaltrials.gov/ct/show/NCT00638443
Objective: Determine efficacy of pregabalin in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients with neurogenic intermittent claudication.
Design: cohort;prospective.
Enrollment: 37
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
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
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
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
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
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
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
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
Outcome Study of Patients Treated With Transitional Cervical Plate Used to Treat Degenerative Disc Disease
Outcome Study of Patients Treated With Transitional Cervical Plate Used to Treat Degenerative Disc Disease
http://www.clinicaltrials.gov/ct/show/NCT00443547
Objective: Measure the benefits of anterior (from the front) cervical (neck) surgery for degenerative disc disease.
Design: Screening, Longitudinal, Defined Population, Prospective Study.
Enrollment: 200
http://www.clinicaltrials.gov/ct/show/NCT00443547
Objective: Measure the benefits of anterior (from the front) cervical (neck) surgery for degenerative disc disease.
Design: Screening, Longitudinal, Defined Population, Prospective Study.
Enrollment: 200
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,
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,
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
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
Posterior Lateral Fusion (PLF) with Dynesys
Posterior Lateral Fusion (PLF) with Dynesys
http://www.clinicaltrials.gov/ct/show/NCT00791180
Objective: Track and document clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
Design: cohort, prospective.
Enrollment: 50
http://www.clinicaltrials.gov/ct/show/NCT00791180
Objective: Track and document clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
Design: cohort, prospective.
Enrollment: 50
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
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
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
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
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, 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
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
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
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
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
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
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
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
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
http://www.clinicaltrials.gov/ct/show/NCT00405691
Objective: Determine whether the TOPS device will effectively treat moderate to severe lumbar stenosis
Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Enrollment: 450
http://www.clinicaltrials.gov/ct/show/NCT00405691
Objective: Determine whether the TOPS device will effectively treat moderate to severe lumbar stenosis
Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Enrollment: 450
Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
http://www.clinicaltrials.gov/ct/show/NCT00335517
Objective: determine the appropriate dose of DepoDur for use in spinal surgery. The study will also assess the safety of this drug in this patient population.
Design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study.
Enrollment: 100
http://www.clinicaltrials.gov/ct/show/NCT00335517
Objective: determine the appropriate dose of DepoDur for use in spinal surgery. The study will also assess the safety of this drug in this patient population.
Design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study.
Enrollment: 100
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
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 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
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
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
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
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
Spine Fusion Instrumented with BMP-2 vs Uninstrumented with Infuse BMP-2 Alone
Spine Fusion Instrumented with BMP-2 vs Uninstrumented with Infuse BMP-2 Alone
http://www.clinicaltrials.gov/ct/show/NCT00405600
Objective: The goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable spine joints. In this research study, bone graft substitute material BMP-2 will be used. No hip bone will be used. The surgical procedure will consist of BMP-2 with or without the use of rods and screws.
Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Enrollment: 50
http://www.clinicaltrials.gov/ct/show/NCT00405600
Objective: The goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable spine joints. In this research study, bone graft substitute material BMP-2 will be used. No hip bone will be used. The surgical procedure will consist of BMP-2 with or without the use of rods and screws.
Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Enrollment: 50
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
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
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
Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord
Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord
http://www.clinicaltrials.gov/ct/show/NCT00631670
Objective: Determine if SBRT is a good way to treat tumors near the spinal cord.
Design: Treatment; non-randomized; open label; parallel assignment; efficacy study.
Enrollment: 550
http://www.clinicaltrials.gov/ct/show/NCT00631670
Objective: Determine if SBRT is a good way to treat tumors near the spinal cord.
Design: Treatment; non-randomized; open label; parallel assignment; efficacy study.
Enrollment: 550
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
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 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
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
Study and Surgical Treatment of Syringomyelia
Study and Surgical Treatment of Syringomyelia
http://www.clinicaltrials.gov/ct/show/NCT0011245
Objective: Study to provide data that a surgical procedure that opens the spinal subarachnoid space corrects the underlying pathophysiology and resolves the syrinx and that the invasion of the spinal cord is unnecessary.
Design: Observational.
Enrollment: 50
http://www.clinicaltrials.gov/ct/show/NCT0011245
Objective: Study to provide data that a surgical procedure that opens the spinal subarachnoid space corrects the underlying pathophysiology and resolves the syrinx and that the invasion of the spinal cord is unnecessary.
Design: Observational.
Enrollment: 50
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
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 a Facet Replacement to Treat Spinal Stenosis
Study of a Facet Replacement to Treat Spinal Stenosis
http://www.clinicaltrials.gov/ct/show/NCT00401518
Objective: Determine if anatomic facet replacement system is effective in the treatment of spinal stenosis.
Design: Treatment, randomized, single blind, active control, parallel assignment, safety/efficacy study.
Enrollment: 300
http://www.clinicaltrials.gov/ct/show/NCT00401518
Objective: Determine if anatomic facet replacement system is effective in the treatment of spinal stenosis.
Design: Treatment, randomized, single blind, active control, parallel assignment, safety/efficacy study.
Enrollment: 300
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
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
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
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 to Compare Two Treatments for Cervical Degenerative Disc Disease
Study to Compare Two Treatments for Cervical Degenerative Disc Disease
http://www.clinicaltrials.gov/ct/show/NCT00700739a
Objective: Compare and performance of Discover Cervical Artificial Disc and anterior cervical discectomy with fusion in the treatment of degenerative disc disease in one level of the cervical spine.
Design: Multicenter; prospective; randomized post-marketing surveillance study.
Enrollment: 293
http://www.clinicaltrials.gov/ct/show/NCT00700739a
Objective: Compare and performance of Discover Cervical Artificial Disc and anterior cervical discectomy with fusion in the treatment of degenerative disc disease in one level of the cervical spine.
Design: Multicenter; prospective; randomized post-marketing surveillance study.
Enrollment: 293
Study to Investigate the Performance of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease
Study to Investigate the Performance of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease
http://www.clinicaltrials.gov/ct/show/NCT00700739
Objective: Evaluate the performance of the Discover cervical Artificial disc in the treatment of degenerative disc disease in one level of the cervical spine.
Design: Interventional; Non-randomized; efficacy study; single group assignment; open label; treatment
Enrollment: 142
http://www.clinicaltrials.gov/ct/show/NCT00700739
Objective: Evaluate the performance of the Discover cervical Artificial disc in the treatment of degenerative disc disease in one level of the cervical spine.
Design: Interventional; Non-randomized; efficacy study; single group assignment; open label; treatment
Enrollment: 142
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
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 Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
http://www.clinicaltrials.gov/ct/show/NCT00510575
Objective: Evaluate amount of radiographic correction obtained using the 5.5mm versus the 6.35mm spinal instrumentation rods.
Design: Treatment; randomized; open label; uncontrolled; parallel assignment; safety/efficacy study.
Enrollment: 300
http://www.clinicaltrials.gov/ct/show/NCT00510575
Objective: Evaluate amount of radiographic correction obtained using the 5.5mm versus the 6.35mm spinal instrumentation rods.
Design: Treatment; randomized; open label; uncontrolled; parallel assignment; safety/efficacy study.
Enrollment: 300
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
http://www.clinicaltrials.gov/ct/show/NCT00444405
Objective: Compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.
Design: Longitudinal, Defined Population, Prospective Study.
Enrollment: 50
http://www.clinicaltrials.gov/ct/show/NCT00444405
Objective: Compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.
Design: Longitudinal, Defined Population, Prospective Study.
Enrollment: 50
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
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
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
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
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
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 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
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
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
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
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
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
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 Malignant Vertebral Fractures with Percutaneous Balloon Kyphoplasty (KYPHOK)
Treatment of Malignant Vertebral Fractures with Percutaneous Balloon Kyphoplasty (KYPHOK)
http://www.clinicaltrials.gov/ct/show/NCT00748631
Objective: Evaluate balloon kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures.
Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.
Enrollment: 60
http://www.clinicaltrials.gov/ct/show/NCT00748631
Objective: Evaluate balloon kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures.
Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.
Enrollment: 60
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
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
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
Ultrasound As Adjunct Therapy for Increasing Fusion Success after Lumbar Surgery
Ultrasound As Adjunct Therapy for Increasing Fusion Success after Lumbar Surgery
http://www.clinicaltrials.gov/ct/show/NCT00744861
Objective: Determine whether using active low intensity pulsed ultrasound as adjunct therapy following single level posterior instrumented lumbar surgery increases the posterolateral success rate when compared to inactive (placebo) therapy.
Design: Double-blind (subject, caregiver, investigator, outcomes assessor); parallel assignment; placebo control; randomized; safety/efficacy study; treatment.
Enrollment: 400
http://www.clinicaltrials.gov/ct/show/NCT00744861
Objective: Determine whether using active low intensity pulsed ultrasound as adjunct therapy following single level posterior instrumented lumbar surgery increases the posterolateral success rate when compared to inactive (placebo) therapy.
Design: Double-blind (subject, caregiver, investigator, outcomes assessor); parallel assignment; placebo control; randomized; safety/efficacy study; treatment.
Enrollment: 400
Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
http://www.clinicaltrials.gov/ct/show/NCT00068822
Objective: Evaluate effectiveness of vertebroplasty for the treatment of fractures secondary to osteoporosis.
Design: Treatment, randomized, double-blind, (subject outcomes assessor), placebo control, crossover assignment, safety/efficacy study.
Enrollment: 294
http://www.clinicaltrials.gov/ct/show/NCT00068822
Objective: Evaluate effectiveness of vertebroplasty for the treatment of fractures secondary to osteoporosis.
Design: Treatment, randomized, double-blind, (subject outcomes assessor), placebo control, crossover assignment, safety/efficacy study.
Enrollment: 294
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
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
World Health Organization Disability Assessment Schedule II (WHODAS-II) for Patients With Symptomatic Lumbar Spinal Stenosis
World Health Organization Disability Assessment Schedule II (WHODAS-II) for Patients With Symptomatic Lumbar Spinal Stenosis
http://www.clinicaltrials.gov/ct/show/NCT00480311
Objective: Determine the measurement characteristics of WHODAS-II (World Health Organization Disability Assessment Schedule II), as well as to analyze its correlation with symptomatic lumbar spinal stenosis (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ), and quality of life (SF-12).
Design: Observational; cross-sectional
Enrollment: 200
http://www.clinicaltrials.gov/ct/show/NCT00480311
Objective: Determine the measurement characteristics of WHODAS-II (World Health Organization Disability Assessment Schedule II), as well as to analyze its correlation with symptomatic lumbar spinal stenosis (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ), and quality of life (SF-12).
Design: Observational; cross-sectional
Enrollment: 200
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
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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