Restore CLINICAL TRIAL
Cervical RadiculopathyDegenerative Disc DiseaseThis is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression. Some participating sites will enroll just M6-C patients, while others will enroll just ACDF patients. Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at one vertebral level from C3 to C7. A total of 243 subjects will be included at up to 20 sites.
Pilot Study to Assess Safety/Prelimary Effectiveness of Prefix in Subjects With Degenerative Disc...
Degenerative Disc DiseaseSpondylolisthesisThis is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from L2-S1.
Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody...
Lumbar Degenerative Disc DiseaseThe purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.
Lumbar Back Bracing Study
Degenerative Disc DiseaseLumbar Spondylosis1 moreThe main objectives of this study are to evaluate the benefits of back bracing in the symptomatic management of patients with CLBP due to degenerative lumbar disc disease. The plan is to study patients with uncomplicated CLBP without symptoms of radiculopathy or neurogenic claudication. The secondary objectives of the study are to evaluate if a back brace provides any additive benefit to usual care consisting of exercise and patient education in patients with CLBP due to degenerative disc disease. Specific Aim 1. To evaluate the effectiveness of back brace to improve pain and patient-reported functional measures in patients with uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy. Hypothesis 1. Back brace in addition to usual care will provide statistically significant improvement in pain and functional measures compared to usual care alone. Specific Aim 2. To evaluate the adherence to back brace wear instructions in patients with uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy Hypothesis 2. Patients with CLBP, due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy, who are prescribed a back brace, will demonstrate clinically acceptable rates of adherence to brace wear instructions.
Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain
Degenerative Disc DiseaseLow Back PainModic changes have been associated with low back pain in many clinical studies and are often considered a part of the disc degeneration process. Modic type 1 change is considered an inflammatory process. The aim of this study is to determine the effectiveness of lumbar transforaminal epidural steroid injections in Modic type-1 changes.
Efficacy of Intradiscal Injection of Viable Placental Tissue Extract in Subjects With One or Two...
Degenerative Disc DiseasePainDr. Parker (the "Investigator") and Semmes Murphey Foundation ("Foundation") are conducting a study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic, P.C. ("Semmes-Murphey"). This study will look at a product that is derived from human tissue, that will be injected into the affected disc. With this study, the investigators hope to find a safe and effective way to treat degenerative disc disease.
OLIF25™ /OLIF51™ Study
Degenerative Disc DiseaseScoliosisThe purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.
RAMP Study: A Study Comparing Two Lumbar Fusion Procedures
Spinal StenosisSpondylolisthesis1 moreThis is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format. This study compares two spinal fusion procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF). Enrollment period will be approximately 12-18 months; each Principal Investigator/Study Center will be expected to enroll up to 20 subjects. The protocol requires approximately 7 subject visits to the study center from screening through the final follow-up visit.
Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System...
Spinal StenosisSpondylolisthesis1 moreThe purpose of this study is to evaluate fusion status and patient outcomes observed from use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the literature reported outcomes of spinal fusion using autograft with posterior stabilization.
Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine
Degenerative Disc DiseaseGrade 1 SpondylolisthesisAn evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.