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AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves
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Friday, May 9, 2008 |
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Clinical Trials
Grant Information and CoursesSpine Clinical Trial Proposal and Fellowship Award Information
Spine Clinical Trial Proposal - $500Spine Clinical Fellowship Award - $50,000
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
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
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
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
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
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
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
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
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
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
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
http://www.clinicaltrials.gov/ct/show/NCT00387829
Objective: Evaluate safety and effectiveness of DuraGen Plus adhesion Barrier Matrix in spinal fusion to reduce fibrosis and radicular pain.
Design: Treatment, Randomized, Double-Blind, Active Control, Safety/Efficacy Study
Enrollment: 500
Dynamic Stabilization for Lumbar Spine Stenosis with Stabilmax NZ® Dynamic Spine Stabilization System
Dynamic Stabilization for Lumbar Spine Stenosis with Stabilmax NZ® Dynamic Spine Stabilization System
http://www.clinicaltrials.gov/ct/show/NCT00479544
Objective: Assess whether the Stabilimax NZ™ is at least as safe and effective as control therapy of fusion in patients receiving surgical decompression for the treatment of symptomatic spinal stenosis at one or two contiguous levels from L1-S1.
Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/efficacy Study.
Enrollment: 480
http://www.clinicaltrials.gov/ct/show/NCT00479544
Objective: Assess whether the Stabilimax NZ™ is at least as safe and effective as control therapy of fusion in patients receiving surgical decompression for the treatment of symptomatic spinal stenosis at one or two contiguous levels from L1-S1.
Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/efficacy Study.
Enrollment: 480
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
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
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
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
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
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
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
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
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
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
http://www.clinicaltrials.gov/ct/show/NCT00056719
Objective: Explore how genes may influence the severity of ankylosing spondylitis, a form of arthritis that affects the spine. Patients have inflammation of the joints of the spine, which may cause the bones of the spine to fuse, resulting in difficulty performing daily activities.
Design: Natural History
Enrollment: 300
Greenwich Lumbar Stenosis SLIP Study
Greenwich Lumbar Stenosis SLIP Study
http://www.clinicaltrials.gov/ct/show/NCT00109213
Objective: determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis).
Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Enrollment: 75
http://www.clinicaltrials.gov/ct/show/NCT00109213
Objective: determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis).
Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Enrollment: 75
IDE Clinical Trial Comparing Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
IDE Clinical Trial Comparing Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
http://www.clinicaltrials.gov/ct/show/NCT00534235
Objective: To evaluate the safety and effectiveness of coflex device compared to control.
Design: Randomized, double-blind, parallel assignment, safety/efficacy study.
Enrollment: 460
http://www.clinicaltrials.gov/ct/show/NCT00534235
Objective: To evaluate the safety and effectiveness of coflex device compared to control.
Design: Randomized, double-blind, parallel assignment, safety/efficacy study.
Enrollment: 460
Infuse® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate Pivotal Clinical Trial
Infuse® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate Pivotal Clinical Trial
http://www.clinicaltrials.gov/ct/show/NCT00485173
Objective: Establish safety/effectiveness of Infuse®Bone Graft, the PEEK Interbody Spacer, and anterior cervical plate in patients with cervical DDD.
Design: Treatment, non-randomized, open label, historical control, single group assignment, safety/efficacy study.
Enrollment: 225
http://www.clinicaltrials.gov/ct/show/NCT00485173
Objective: Establish safety/effectiveness of Infuse®Bone Graft, the PEEK Interbody Spacer, and anterior cervical plate in patients with cervical DDD.
Design: Treatment, non-randomized, open label, historical control, single group assignment, safety/efficacy study.
Enrollment: 225
KAVIAR Study-Kyphoplasty and Vertebroplasty in the Augmentation and Restoration of Vertebral Body Compression Fractures
KAVIAR Study-Kyphoplasty and Vertebroplasty in the Augmentation and Restoration of Vertebral Body Compression Fractures
http://www.clinicaltrials.gov/ct/show/NCT00323609
Objective: Patients with compression fractures randomized to kyphoplasty or vertebroplasty for comparison.
Design: Treatment, randomized, open label, active control, parallel assignment, safety/efficacy study.
Enrollment: 1,234
http://www.clinicaltrials.gov/ct/show/NCT00323609
Objective: Patients with compression fractures randomized to kyphoplasty or vertebroplasty for comparison.
Design: Treatment, randomized, open label, active control, parallel assignment, safety/efficacy study.
Enrollment: 1,234
Kineflex-C Artificial Disc System to Treat Cervical DDD
Kineflex-C Artificial Disc System to Treat Cervical DDD
http://www.clinicaltrials.gov/ct/show/NCT00374413
Objective: The Kineflex-C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 toC7
Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Bio-equivalence Study
Enrollment: 350
http://www.clinicaltrials.gov/ct/show/NCT00374413
Objective: The Kineflex-C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 toC7
Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Bio-equivalence Study
Enrollment: 350
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
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
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
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
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
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
http://www.clinicaltrials.gov/ct/show/NCT00294151
Objective: Aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone.
Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study.
Enrollment: 30
Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusion
Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusion
http://www.clinicaltrials.gov/ct/show/NCT00555659
Objective: Assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made.
Design: Treatment, Non-Randomized, Open Label, Single Group Assignment.
Enrollment: 200
http://www.clinicaltrials.gov/ct/show/NCT00555659
Objective: Assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made.
Design: Treatment, Non-Randomized, Open Label, Single Group Assignment.
Enrollment: 200
Response Shift in Patient Expectations and Functional Outcome
Response Shift in Patient Expectations and Functional Outcome
http://www.clinicaltrials.gov/ct/show/NCT00289393
Objective: Evaluate the results of elective lumbar spinal surgery as it relates to shifting patient expectations for outcome. Patients undergoing elective posterior spinal surgery for degenerative conditions of the spine at SWCHSC will be evaluated.
Design: Longitudinal, Defined Population, Retrospective/Prospective Study
Enrollment: Not listed
http://www.clinicaltrials.gov/ct/show/NCT00289393
Objective: Evaluate the results of elective lumbar spinal surgery as it relates to shifting patient expectations for outcome. Patients undergoing elective posterior spinal surgery for degenerative conditions of the spine at SWCHSC will be evaluated.
Design: Longitudinal, Defined Population, Retrospective/Prospective Study
Enrollment: Not listed
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
http://www.clinicaltrials.gov/ct/show/NCT00405691
Objective: Determine whether the TOPS device will effectively treat moderate to severe lumbar stenosis
Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Enrollment: 450
http://www.clinicaltrials.gov/ct/show/NCT00405691
Objective: Determine whether the TOPS device will effectively treat moderate to severe lumbar stenosis
Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Enrollment: 450
Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
http://www.clinicaltrials.gov/ct/show/NCT00335517
Objective: determine the appropriate dose of DepoDur for use in spinal surgery. The study will also assess the safety of this drug in this patient population.
Design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study.
Enrollment: 100
http://www.clinicaltrials.gov/ct/show/NCT00335517
Objective: determine the appropriate dose of DepoDur for use in spinal surgery. The study will also assess the safety of this drug in this patient population.
Design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study.
Enrollment: 100
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
http://www.clinicaltrials.gov/ct/show/NCT00344890
Objective: compare the safety and efficacy of Preservon(TM) treated allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or myelopathy.
Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Enrollment: 120
http://www.clinicaltrials.gov/ct/show/NCT00344890
Objective: compare the safety and efficacy of Preservon(TM) treated allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or myelopathy.
Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Enrollment: 120
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
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
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
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
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
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
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
http://www.clinicaltrials.gov/ct/show/NCT00444405
Objective: Compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.
Design: Longitudinal, Defined Population, Prospective Study.
Enrollment: 50
Surgical Treatment of Cervical Spondylotic Myelopathy
Surgical Treatment of Cervical Spondylotic Myelopathy
http://www.clinicaltrials.gov/ct/show/NCT00565734
Objective: Compare anterior and posterior surgical approach in treatment of CSM and to compare variations in treatment and outcomes of CSM worldwide.
Design: Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study.
Enrollment: 375
http://www.clinicaltrials.gov/ct/show/NCT00565734
Objective: Compare anterior and posterior surgical approach in treatment of CSM and to compare variations in treatment and outcomes of CSM worldwide.
Design: Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study.
Enrollment: 375
Synvisc Injections for Lumbar Facet Joint Pain
Synvisc Injections for Lumbar Facet Joint Pain
http://www.clinicaltrials.gov/ct/show/NCT00325845
Objective: Evaluate the safety and efficacy of viscosupplementation in treating symptomatic lumbar facet joint arthropathy.
Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.
Enrollment: 15
http://www.clinicaltrials.gov/ct/show/NCT00325845
Objective: Evaluate the safety and efficacy of viscosupplementation in treating symptomatic lumbar facet joint arthropathy.
Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.
Enrollment: 15
The CSM Trial: A Multicenter Study Comparing ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy
The CSM Trial: A Multicenter Study Comparing ventral to Dorsal Surgery for
Cervical Spondylotic Myelopathy
http://www.clinicaltrials.gov/ct/show/NCT00506558
Objective: To determine the optimal surgical approach (ventral versus dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM).
Design: Treatment, non-randomized, open label, active control, parallel assignment, safety/efficacy study
Enrollment: 100
http://www.clinicaltrials.gov/ct/show/NCT00506558
Objective: To determine the optimal surgical approach (ventral versus dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM).
Design: Treatment, non-randomized, open label, active control, parallel assignment, safety/efficacy study
Enrollment: 100
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
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
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
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
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
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
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
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
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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