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AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves | ||||||
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Clinical TrialsGrant Information and CoursesSpine Clinical Trial Proposal and Fellowship Award InformationSpine Clinical Trial Proposal - $500Spine Clinical Fellowship Award - $50,000 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 Randomized Trial Comparing SpineJet Hydrodiscectomy to Open Lumbar Microdiscectomy for treatment of Lumbar Radiculopathy Due to Disc Herniation A Randomized Trial Comparing SpineJet Hydrodiscectomy to Open Lumbar Microdiscectomy for treatment of Lumbar Radiculopathy Due to Disc Herniation http://www.clinicaltrials.gov/ct/show/NCT00384007 Objective: Compare standard surgical procedure, open microdiscectomy to a newer surgical procedure hydrodiscectomy with Spinejet for lumbar radiculopathy due to disc herniation. Design: Treatment, Randomized, open label, active control, parallel assignment, safety/efficacy study. Enrollment: 58 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 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 C-Tek Fusion Study C-Tek Fusion Study http://www.clinicaltrials.gov/ct/show/NCT00585923 Objective: Compare the fusion rates between the EBI, L.P. C-TEK™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design. Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment. Enrollment: 154 CAFE Study-Cancer Patient Fracture Evaluation CAFE Study-Cancer Patient Fracture Evaluation http://www.clinicaltrials.gov/ct/show/NCT00211237 Objective: Evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer. Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study. Enrollment: 200 CHARITE™ vs. ALIF 5-year Follow-up CHARITE™ vs. ALIF 5-year Follow-up http://www.clinicaltrials.gov/ct/show/NCT00215332 Objective: Assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1). Design: Natural History, Longitudinal, Defined Population, Prospective Study. Enrollment: 367 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 Collection of Tumor Tissue, Blood and Spinal Fluid from Patients with Brain or Spinal Tumors Collection of Tumor Tissue, Blood and Spinal Fluid from Patients with Brain or Spinal Tumors http://www.clinicaltrials.gov/ct/show/NCT00580463 Objective: Collect samples of brain and spinal cord tumors, blood and spinal fluid in order to use them in cancer research. Design: Case-Only, Prospective. Enrollment: 1200 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 Disc Prosthesis Versus Multidisciplinary Rehabilitation Disc Prosthesis Versus Multidisciplinary Rehabilitation http://www.clinicaltrials.gov/ct/show/NCT00394732 Objective: Compare total disc replacement to non-surgical treatment. Design: Treatment, randomized, single blind, active control, parallel assignment, safety/efficacy study. Enrollment: 180 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 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 Effects of X-STOP® Versus Laminectomy Study Effects of X-STOP® Versus Laminectomy Study http://www.clinicaltrials.gov/ct/show/NCT00558129 Objective: Determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that of conventional laminectomy in patients with lumbar spinal stenosis. Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study. Enrollment: 154 Evaluating the Safety and Effectiveness of the Neodisc™ Versus ACDF in Subjects with Single-Level Cervical Disc Disease Evaluating the Safety and Effectiveness of the Neodisc™ Versus ACDF in Subjects with Single-Level Cervical Disc Disease http://www.clinicaltrials.gov/ct/show/NCT00478088 Objective: Evaluate the safety and effectiveness of Neodisc compared to ACDF for the treatment of single-level cervical disc disease. Design: Treatment, randomized, single blind, active control, single group assignment, safety/efficacy study. Enrollment: 488 Evaluation and Treatment of Patients Spinal Blood Vessel Abnormalities Evaluation and Treatment of Patients Spinal Blood Vessel Abnormalities http://www.clinicaltrials.gov/ct/show/NCT00001364 Objective: This study is designed to increase researchers understanding of AVMs by admitting and following patients diagnosed with the condition. By increasing the amount of patients studied diagnosed with spinal blood vessel abnormalities, researchers can begin to develop new management plans for patients with AVMs. Design: Natural History Enrollment: 120 Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) http://www.clinicaltrials.gov/ct/show/NCT00508443 Objective: Establish safety/feasibility of using novel CT-on-Rails or Trilogy stereotactic spine radiotherapy system to treat spine and para-spinal tumors. Design: Treatment, non-randomized, open label, uncontrolled, single group assignment, safety/efficacy study. Enrollment: 150 Evaluation of PediGuard™ for Pedicle Screw Insertion Evaluation of PediGuard™ for Pedicle Screw Insertion http://www.clinicaltrials.gov/ct/show/NCT00549627 Objective: Determine the relative effectiveness of the PediGuardTM for pedicle screw placement pilot (drill) hole and for reducing pedicle screw breaches during thoracic and lumbar pedicle screw fixation of the spine. Design: Other, Randomized, Open Label, Placebo Control, Parallel Assignment. Enrollment: None listed Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograph Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograph http://www.clinicaltrials.gov/ct/show/NCT00254852 Objective: Compare Optecure™ as an auto graft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine (one level is defined as two adjacent vertebrae), L2 and below. Design: Treatment, Randomized, Single Blind, Active Control, Parallel 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 Evaluation of Vertebroplasty Associated with Radiotherapy for Spine Metastases (EVAR) Evaluation of Vertebroplasty Associated with Radiotherapy for Spine Metastases (EVAR) http://www.clinicaltrials.gov/ct/show/NCT00267033 Objective: Use randomized trial to test the association of vertebroplasty and radiotherapy to enhance pain relief for patients with painful osseous spine metastases. Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study. Enrollment: 186 Genetic Determinants of Ankylosing Spondylitis Severity Genetic Determinants of Ankylosing Spondylitis Severity http://www.clinicaltrials.gov/ct/show/NCT00056849 Objective: Explore how genes-units of heredity-may influence the severity of ankylosing spondylitis. It will examine whether some genes may cause people with ankylosing spondylitis to have more rapid fusion of the bones of the spine, more difficulty performing daily activities, or be more likely to need joint surgery. Design: Natural History Enrollment: 500 Genetic Determinants of Ankylosing Spondylitis Severity- Longitudinal Study Genetic Determinants of Ankylosing Spondylitis Severity- Longitudinal Study http://www.clinicaltrials.gov/ct/show/NCT00056719 Objective: Explore how genes may influence the severity of ankylosing spondylitis, a form of arthritis that affects the spine. Patients have inflammation of the joints of the spine, which may cause the bones of the spine to fuse, resulting in difficulty performing daily activities. Design: Natural History Enrollment: 300 Greenwich Lumbar Stenosis SLIP Study Greenwich Lumbar Stenosis SLIP Study http://www.clinicaltrials.gov/ct/show/NCT00109213 Objective: determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study Enrollment: 75 IDE Clinical Trial Comparing Coflex vs. Fusion to Treat Lumbar Spinal Stenosis IDE Clinical Trial Comparing Coflex vs. Fusion to Treat Lumbar Spinal Stenosis http://www.clinicaltrials.gov/ct/show/NCT00534235 Objective: To evaluate the safety and effectiveness of coflex device compared to control. Design: Randomized, double-blind, parallel assignment, safety/efficacy study. Enrollment: 460 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 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 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 LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE http://www.clinicaltrials.gov/ct/show/NCT00389597 Objective: Establish the safety and effectiveness of the LDR Spine Mobi-C Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device. Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study Enrollment: 327 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 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 Percutaneous Vertebroplasty Versus Conservative Treatment of Pain Percutaneous Vertebroplasty Versus Conservative Treatment of Pain http://www.clinicaltrials.gov/ct/show/NCT00203554 Objective: Compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients. Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study. Enrollment: 50 Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar 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 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 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 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 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 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 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 Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine http://www.clinicaltrials.gov/ct/show/NCT00577226 Objective: Retrospective review of patients who have undergone this procedure and will prospectively follow patients undergoing the procedure in the future looking at curvature over time, diagnosis, pulmonary function, surgeries and spine growth. Design: Treatment, open label, single group assignment. Enrollment: 50 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 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 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 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 Surgical Management of Spinal Cord Injuries In Neck Surgical Management of Spinal Cord Injuries In Neck http://www.clinicaltrials.gov/ct/show/NCT00475748 Objective: In acute traumatic central cord syndrome, compare surgical decompression of the spinal cord within 5 days with decompression 6 weeks following injury. Design: Single center prospective randomized study. Enrollment: 30 Surgical Treatment 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 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 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 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 To Evaluate Success of Cement Treatment of Spinal Compression Fractures 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 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 Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery http://www.clinicaltrials.gov/ct/show/NCT00152152 Objective: Radiostereometric Analysis (RSA) is a new imaging technique used to measure motions in the spine. It provides more accurate measurements that could help in diagnosing problems in the spine earlier than standard xray techniques. Design: Longitudinal, Defined Population, Prospective Study Enrollment: 75 Use of Radiostereometric Analysis Following Spinal Fusion; Radiostereometric Analysis Following Surgery with DYNESYS Stabilization System Use of Radiostereometric Analysis Following Spinal Fusion; Radiostereometric Analysis Following Surgery with DYNESYS Stabilization System http://www.clinicaltrials.gov/ct/show/NCT00152165 Objective: Assess the amount of motion in the lumbar spine in patients with a dynamic stabilization system, DYNESYS. Two questions will be examined in this study: 1) what is the amount of flexion/extension and lateral bending motion that occurs in the spine with a dynamic stabilization system in relation to a lumbar interbody fusion procedure? and 2) will the amount of motion change during the time frame of the study? Design: Longitudinal, Random Sample, Prospective Study Enrollment: 12 Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis-CLEOS Study Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis-CLEOS Study http://www.clinicaltrials.gov/ct/show/NCT00252551 Objective: Evaluate superiority of the osteosynthesis associated with a decompressive surgery as compared to a single decompressive surgery in the treatment of lumbar degenerative stenosis with spondylolisthesis. Design: Treatment, randomized, open label, active control, parallel assignment, safety/efficacy study. Enrollment: 152 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 VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Treatment VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Treatment http://www.clinicaltrials.gov/ct/show/NCT00232466 Objective: Randomized controlled trial to compare percutaneous vertebroplasty vs. conservative treatment mid-term. Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study. Enrollment: 200 Wallis Stabilization System for Low Back Pain Wallis Stabilization System for Low Back Pain http://www.clinicaltrials.gov/ct/show/NCT00484458 Objective: Demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar spine at the L4-L5 level. Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study. Enrollment: 340 |
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