GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study

Cervicobrachial Neuralgia Clinical Trial

Official title:

The GRANVIA®-C Cervical Disc Prosthesis to Treat Symptomatic Degenerative Disc Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518582
• Other study ID #: #0802
• 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

Related Conditions & MeSH terms

• Cervical Discopathy
• Cervicobrachial Neuralgia
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Neuralgia

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