Status:
COMPLETED
GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study
Lead Sponsor:
Medicrea International
Conditions:
Cervicobrachial Neuralgia
Cervical Discopathy
Eligibility:
All Genders
21-55 years
Brief 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...
Detailed Description
Anterior cervical arthrodesis has been widely used to treat the degenerative cervical spine. Although the results of ACDF are generally in the good to excellent range, interbody fusion of the cervical...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01518582
Start Date
August 1 2012
End Date
June 1 2016
Last Update
June 28 2016
Active Locations (3)
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1
CHR Namur
Namur, Belgium, 5000
2
Tripode Hospital
Bordeaux, France, 33000
3
Clairval hospital
Marseille, France, 13009