Clinical trial NCT01518582: GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study
Official title: The GRANVIA®-C Cervical Disc Prosthesis to Treat Symptomatic Degenerative Disc Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervicobrachial Neuralgia
Cervical Discopathy
Keywords: Cervicobrachial
neuralgia
symptomatic cervical discopathy
Lead sponsor: Medicrea International
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Cervicobrachial neuralgia due to symptomatic cervical discopathy

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.

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 (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

Primary outcomes:
measure: Composite criterion of success
timeFrame: 24Months
Secondary outcomes:
measure: Radiologic evaluation of the motion
timeFrame: Preop, 3M, 12M and 24M
measure: Evaluation of potential peri and post-operative adverse events related or not to prosthesis.
timeFrame: preop, 3M, 12M, 24M
measure: Evaluation of satisfaction
timeFrame: Preop, 3M, 12M and 24M
measure: Evaluation of the time to return to activities (normal activity, work, sport activity)
timeFrame: preop, 3M, 12M, 24M
measure: Evaluation of Pain
timeFrame: Preop, 3M, 12M and 24M
measure: cervical alignment
timeFrame: Preop, 3M, 12M and 24M
measure: disc height
timeFrame: Preop, 3M, 12M and 24M
measure: Radiologic adverse events
timeFrame: Preop, 3M, 12M and 24M
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: CHR Namur
city: Bordeaux
country: France
facility: Tripode Hospital
city: Marseille
country: France
facility: Clairval hospital
Study officials:
affiliation: Royal London Hospital, UK
name: John Yeh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHC Liège, Belgium
name: Frédéric Schils, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Halle Klinike, Germany
name: Hans Meisel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Patrick Guérin, MD
role: PRINCIPAL_INVESTIGATOR
References: