GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study (NCT01518582) | Clinical Trial Compass
CompletedNot Applicable
GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study
Belgium, France70 participantsStarted 2012-08
Plain-language summary
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.
Who can participate
Age range21 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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