Cervicobrachial Neuralgia Clinical Trial
Official title:
The GRANVIA®-C Cervical Disc Prosthesis to Treat Symptomatic Degenerative Disc Diseases
This is a prospective clinical study to assess the performance of the prosthesis according
to a composite success criterion. The clinical and functional results and the patient's
quality of life up to 24 months of follow-up will also be recorded.
Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.
Status | Completed |
Enrollment | 70 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Cervicobrachial neuralgia due to symptomatic cervical discopathy - Presence of pain (arm or arm and neck) and/or a neurologic deficit with a radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following: - Herniated nucleus pulposus - Spondylosis (defined by the presence of osteophytes) - Degenerative Disc Disease at a single level or 2-level(s) adjacent or not between C3 and C7 Exclusion Criteria (non exhaustive): - Asymptomatic degenerative disc disease (DDD) - DDD of 3-levels or more - Axial neck pain as the solitary symptom - Severe spondylosis at the level to be treated by arthroplasty as - Characterized by any of the following: - Bridging osteophytes - A loss of disc height greater than 50% (compared to adjacent levels) - Absence of motion (<2°) - Any prior spine surgery at any cervical level, especially fusion procedure; views) for the level operated by arthroplasty - Tumor - Deformity or fracture of the cervical vertebrae - Active systemic infection or infection at the operative site(s) - Pregnant or interested in becoming pregnant in the next three years; - Advanced emphysema, Alzheimer's disease or other medical conditions that would interfere with patient self-assessment of function, pain or quality of life |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | CHR Namur | Namur | |
France | Tripode Hospital | Bordeaux | |
France | Clairval hospital | Marseille |
Lead Sponsor | Collaborator |
---|---|
Medicrea International |
Belgium, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite criterion of success | the success is defined by a composite criterion of 4 points. The surgery will be a success only if there is: A 15-point improvement in the NDI score from the preoperative baseline score Maintenance or improvement of the pre-op baseline neurological status Absence of secondary surgical intervention Absence of serious adverse event |
24Months | Yes |
Secondary | Radiologic evaluation of the motion | Radiologic evaluation of the motion of the operated level(s) and comparison to the motion of the adjacent levels, | Preop, 3M, 12M and 24M | No |
Secondary | Evaluation of potential peri and post-operative adverse events related or not to prosthesis. | preop, 3M, 12M, 24M | Yes | |
Secondary | Evaluation of satisfaction | Evaluation of satisfaction with Patient Satisfaction Index | Preop, 3M, 12M and 24M | No |
Secondary | Evaluation of the time to return to activities (normal activity, work, sport activity) | preop, 3M, 12M, 24M | No | |
Secondary | Evaluation of Pain | Evaluation of pain with Visual Analog Scales | Preop, 3M, 12M and 24M | No |
Secondary | cervical alignment | Radiologic evaluation of the global cervical alignment | Preop, 3M, 12M and 24M | No |
Secondary | disc height | Radiologic evaluation of the disc height of the operated level(s) | Preop, 3M, 12M and 24M | No |
Secondary | Radiologic adverse events | Radiologic evaluation of adverse events such as migration, subsidence | Preop, 3M, 12M and 24M | No |
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