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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01518582
Other study ID # #0802
Secondary ID
Status Completed
Phase N/A
First received January 5, 2012
Last updated June 27, 2016
Start date August 2012
Est. completion date June 2016

Study information

Verified date June 2016
Source Medicrea International
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Committee for the Protection of PersonnesFrance: Conseil National de l'Ordre des Médecins
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Device:
Cervical arthroplasty surgery with Granvia-C
Discectomy and Cervical arthroplasty according to standard practice of the surgeon

Locations

Country Name City State
Belgium CHR Namur Namur
France Tripode Hospital Bordeaux
France Clairval hospital Marseille

Sponsors (1)

Lead Sponsor Collaborator
Medicrea International

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

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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