GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study

NCT ID: NCT01518582

Last Updated: 2016-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-06-30

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 24 months of follow-up will also be recorded.

Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.

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.

Conditions

Cervicobrachial Neuralgia; Cervical Discopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Radiculopathy Cervical

Radiculopathy, Cervical

Cervical arthroplasty surgery with Granvia-C

Intervention Type: DEVICE

Discectomy and Cervical arthroplasty according to standard practice of the surgeon

Interventions

Cervical arthroplasty surgery with Granvia-C

Discectomy and Cervical arthroplasty according to standard practice of the surgeon

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medicrea International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Yeh, MD

Role: PRINCIPAL_INVESTIGATOR

Royal London Hospital, UK

Frédéric Schils, MD

Role: PRINCIPAL_INVESTIGATOR

CHC Liège, Belgium

Hans Meisel, MD

Role: PRINCIPAL_INVESTIGATOR

Halle Klinike, Germany

Patrick Guérin, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHR Namur

Namur, , Belgium

Tripode Hospital

Bordeaux, , France

Clairval hospital

Marseille, , France

Countries

Belgium; France

Other Identifiers

#0802

Identifier Type: -

Identifier Source: org_study_id