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
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, 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 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

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 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
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

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
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
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

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)
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.
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
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
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)
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
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)
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
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
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
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
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
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 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)
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
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
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)
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)
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

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

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
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

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)
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
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 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
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

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 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
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

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)
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)
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
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
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
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
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
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

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

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

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
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

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
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
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
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)
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
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)
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)
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

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)
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
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 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,

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
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

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
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

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

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, 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

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
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
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)
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
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
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 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
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 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
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
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

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

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
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

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
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 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
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 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)
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 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

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)
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
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
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
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

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 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

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)
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
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
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
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
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
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)
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)
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
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
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)
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
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

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

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
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
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)
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
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