View clinical trials related to Myelopathy.
Filter by:This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. The information obtained from this clinical investigation will be used to support the post market surveillance for a PMA supplement for the PRESTIGE LP™ Cervical Disc implanted at two contiguous levels.
A Prospective, open label, multi-center observational study of patients requiring surgical treatment at one or two (contiguous) cervical spine levels. The primary objectives of the RHINE Cervical Disc study are to: obtain operative data and feedback on surgical instruments and surgical technique; confirm device performance in terms of clinical and radiographic outcomes; confirm device performance in terms of safety and to collect original data to be compared to published reports of the performance of comparable motion-sparing devices, as well as clinical outcomes of fusion devices.
Hypotheses: Decompressive surgery of cervical myelopathy will improve bladder function. Decompressive surgery of cervical myelopathy will improve sexual function.
The purpose of this study is firstly to determine the efficacy of cervical plate for anterior cervical discectomy and fusion using cervical cage, and secondly to investigate the determining factors for surgical outcomes.
On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.
This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
The objective of this pilot study is to determine if degenerative spinal disorders such as acute radiculopathy, myelopathy, stenosis, or disc and facet disease cause detectable alterations in Substance P levels in saliva, serum and cerebrospinal fluid. If this pilot study shows a correlation between Substance P levels and pain associated with degenerative spinal disorders, then a larger study will be initiated to determine the feasibility of using Substance P levels in the diagnosis and treatment of degenerative spinal disease.
The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.
The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.
The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.