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GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01518582
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : June 28, 2016
Information provided by (Responsible Party):
Medicrea International

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.

Condition or disease Intervention/treatment
Cervicobrachial Neuralgia Cervical Discopathy Device: Cervical arthroplasty surgery with Granvia-C

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.

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The GRANVIA®-C Cervical Disc Prosthesis to Treat Symptomatic Degenerative Disc Diseases
Study Start Date : August 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Group/Cohort Intervention/treatment
Radiculopathy Cervical
Radiculopathy, Cervical
Device: Cervical arthroplasty surgery with Granvia-C
Discectomy and Cervical arthroplasty according to standard practice of the surgeon

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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,

  2. Evaluation of potential peri and post-operative adverse events related or not to prosthesis. [ Time Frame: preop, 3M, 12M, 24M ]
  3. Evaluation of satisfaction [ Time Frame: Preop, 3M, 12M and 24M ]
    Evaluation of satisfaction with Patient Satisfaction Index

  4. Evaluation of the time to return to activities (normal activity, work, sport activity) [ Time Frame: preop, 3M, 12M, 24M ]
  5. Evaluation of Pain [ Time Frame: Preop, 3M, 12M and 24M ]
    Evaluation of pain with Visual Analog Scales

  6. cervical alignment [ Time Frame: Preop, 3M, 12M and 24M ]
    Radiologic evaluation of the global cervical alignment

  7. disc height [ Time Frame: Preop, 3M, 12M and 24M ]
    Radiologic evaluation of the disc height of the operated level(s)

  8. Radiologic adverse events [ Time Frame: Preop, 3M, 12M and 24M ]
    Radiologic evaluation of adverse events such as migration, subsidence

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with Cervicobrachial neuralgia due to symptomatic cervical discopathy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01518582

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CHR Namur
Namur, Belgium, 5000
Tripode Hospital
Bordeaux, France, 33000
Clairval hospital
Marseille, France, 13009
Sponsors and Collaborators
Medicrea International
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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

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Responsible Party: Medicrea International Identifier: NCT01518582     History of Changes
Other Study ID Numbers: #0802
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Keywords provided by Medicrea International:
symptomatic cervical discopathy
Additional relevant MeSH terms:
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Brachial Plexus Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Brachial Plexus Neuropathies