GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study

Medicrea

Status: Completed

Conditions: Cervicobrachial Neuralgia; Cervical Discopathy

Treatments: Device: Cervical arthroplasty surgery with Granvia-C

Study type: Observational

Funder types: Industry

Identifiers

NCT01518582

#0802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 (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

Trial design

70 participants in 1 patient group

Radiculopathy Cervical

Description:

Radiculopathy, Cervical

Treatment:

Device: Cervical arthroplasty surgery with Granvia-C