GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study

June 27, 2016 updated by: Medicrea International

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Namur, Belgium, 5000
        • CHR Namur
      • Bordeaux, France, 33000
        • Tripode Hospital
      • Marseille, France, 13009
        • Clairval Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with Cervicobrachial neuralgia due to symptomatic cervical discopathy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radiculopathy Cervical
Radiculopathy, Cervical
Discectomy and Cervical arthroplasty according to standard practice of the surgeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite criterion of success
Time Frame: 24Months

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiologic evaluation of the motion
Time Frame: Preop, 3M, 12M and 24M
Radiologic evaluation of the motion of the operated level(s) and comparison to the motion of the adjacent levels,
Preop, 3M, 12M and 24M
Evaluation of potential peri and post-operative adverse events related or not to prosthesis.
Time Frame: preop, 3M, 12M, 24M
preop, 3M, 12M, 24M
Evaluation of satisfaction
Time Frame: Preop, 3M, 12M and 24M
Evaluation of satisfaction with Patient Satisfaction Index
Preop, 3M, 12M and 24M
Evaluation of the time to return to activities (normal activity, work, sport activity)
Time Frame: preop, 3M, 12M, 24M
preop, 3M, 12M, 24M
Evaluation of Pain
Time Frame: Preop, 3M, 12M and 24M
Evaluation of pain with Visual Analog Scales
Preop, 3M, 12M and 24M
cervical alignment
Time Frame: Preop, 3M, 12M and 24M
Radiologic evaluation of the global cervical alignment
Preop, 3M, 12M and 24M
disc height
Time Frame: Preop, 3M, 12M and 24M
Radiologic evaluation of the disc height of the operated level(s)
Preop, 3M, 12M and 24M
Radiologic adverse events
Time Frame: Preop, 3M, 12M and 24M
Radiologic evaluation of adverse events such as migration, subsidence
Preop, 3M, 12M and 24M

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John Yeh, MD, Royal London Hospital, UK
  • Principal Investigator: Frédéric Schils, MD, CHC Liège, Belgium
  • Principal Investigator: Hans Meisel, MD, Halle Klinike, Germany
  • Principal Investigator: Patrick Guérin, MD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 26, 2012

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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