NCT01518582

GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Medicrea International · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Cervical arthroplasty surgery with Granvia-C	Discectomy and Cervical arthroplasty according to standard practice of the surgeon

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2012-01-26
• Last updated: 2016-06-28

Locations

3 sites across 2 countries: Belgium, France