Clinical Trials

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 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

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

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

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

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 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

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 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

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

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

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

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

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

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 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

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: 122

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

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

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

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

Enrollment: 60

Evaluation of the 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

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

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

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

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

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

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

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 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

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

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

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

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

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 to Assess the Efficacy and Safety of the Lubo Cervical Collar
http://www.clinicaltrials.gov/ct/show/NCT00355173

Objective: The Lubo collar is a device that simultaneously maintains cervical spine control and keeps an open airway in a non-invasive manner that is simple to operate. The objective of the study is to test the safety of the collar volunteers.

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

Enrollment: None listed

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

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

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

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 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

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 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

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

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 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

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 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

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

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

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 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 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

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 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

Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injury
http://www.clinicaltrials.gov/ct/show/NCT00004445

Objective: Establish the procedures for implementing and assessing the clinical utility of functional neuromuscular stimulation using an implanted 8 channel standing and transfer system in patients with complete teraplegia or paraplegia.

Design: Treatment; non-randomized.

Enrollment: 17

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

Study to Compare Two Treatments for Cervical Degenerative Disc Disease
http://www.clinicaltrials.gov/ct/show/NCT00700739

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

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 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

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

To Evaluate Success of Cement Treatment of Spinal Compression Fractures
http://www.clinicaltrials.gov/ct/show/NCT00166374

Objective: Patients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.

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

Enrollment: 200

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 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

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

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

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