- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01518582
GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 spine after cervical discectomy, aside from causing restriction of neck movements, also accelerates degeneration of adjacent disc levels because of the increased stress from fusion. Long-term radiographic follow-up of patients with anterior cervical fusion has demonstrated degenerative changes in the non-fused segments of the spine including disc space narrowing and osteophyte formation.
To conclude, fusion provokes a functional overload of the discs bordering the fusion that is directly correlated to the number of fused levels. Radiographic observations show a greater mechanical stress on the discs, especially in the arthrodeses involving more than one level.
Artificial discs were designed to replace the entire intervertebral disc and to preserve the physiological motion of the operated level. Several prostheses with different concepts were commercialized. Published clinical studies reported a preserved motion and improved clinical results (Neck Disability Index, Pain Visual Analogic Scale, Quality of Life).
The cervical disc prosthesis GRANVIA®-C was designed to replace the intervertebral discs of the cervical spine, to restore the disc height and to restore segmental motion.
A prospective clinical study has been set up to evaluate the performance of the prosthesis
Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.
Study Type
Enrollment (Actual)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Radiculopathy Cervical
Radiculopathy, Cervical
|
Discectomy and Cervical arthroplasty according to standard practice of the surgeon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite criterion of success
Time Frame: 24Months
|
the success is defined by a composite criterion of 4 points. The surgery will be a success only if there is:
|
24Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiologic evaluation of the motion
Time Frame: Preop, 3M, 12M and 24M
|
Radiologic evaluation of the motion of the operated level(s) and comparison to the motion of the adjacent levels,
|
Preop, 3M, 12M and 24M
|
Evaluation of potential peri and post-operative adverse events related or not to prosthesis.
Time Frame: preop, 3M, 12M, 24M
|
preop, 3M, 12M, 24M
|
|
Evaluation of satisfaction
Time Frame: Preop, 3M, 12M and 24M
|
Evaluation of satisfaction with Patient Satisfaction Index
|
Preop, 3M, 12M and 24M
|
Evaluation of the time to return to activities (normal activity, work, sport activity)
Time Frame: preop, 3M, 12M, 24M
|
preop, 3M, 12M, 24M
|
|
Evaluation of Pain
Time Frame: Preop, 3M, 12M and 24M
|
Evaluation of pain with Visual Analog Scales
|
Preop, 3M, 12M and 24M
|
cervical alignment
Time Frame: Preop, 3M, 12M and 24M
|
Radiologic evaluation of the global cervical alignment
|
Preop, 3M, 12M and 24M
|
disc height
Time Frame: Preop, 3M, 12M and 24M
|
Radiologic evaluation of the disc height of the operated level(s)
|
Preop, 3M, 12M and 24M
|
Radiologic adverse events
Time Frame: Preop, 3M, 12M and 24M
|
Radiologic evaluation of adverse events such as migration, subsidence
|
Preop, 3M, 12M and 24M
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Yeh, MD, Royal London Hospital, UK
- Principal Investigator: Frédéric Schils, MD, CHC Liège, Belgium
- Principal Investigator: Hans Meisel, MD, Halle Klinike, Germany
- Principal Investigator: Patrick Guérin, MD, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #0802
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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