GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Medicrea International
Sponsor:
Information provided by (Responsible Party):
Medicrea International
ClinicalTrials.gov Identifier:
NCT01518582
First received: January 5, 2012
Last updated: September 11, 2012
Last verified: July 2012
  Purpose

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 Intervention
Cervicobrachial Neuralgia
Cervical Discopathy
Device: Cervical arthroplasty surgery with Granvia-C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The GRANVIA®-C Cervical Disc Prosthesis to Treat Symptomatic Degenerative Disc Diseases

Further study details as provided by Medicrea International:

Primary Outcome Measures:
  • Composite criterion of success [ Time Frame: 24Months ] [ Designated as safety issue: Yes ]

    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:
  • Radiologic evaluation of the motion [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
    Radiologic evaluation of the motion of the operated level(s) and comparison to the motion of the adjacent levels,

  • Evaluation of potential peri and post-operative adverse events related or not to prosthesis. [ Time Frame: preop, 3M, 12M, 24M ] [ Designated as safety issue: Yes ]
  • Evaluation of satisfaction [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
    Evaluation of satisfaction with Patient Satisfaction Index

  • Evaluation of the time to return to activities (normal activity, work, sport activity) [ Time Frame: preop, 3M, 12M, 24M ] [ Designated as safety issue: No ]
  • Evaluation of Pain [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
    Evaluation of pain with Visual Analog Scales

  • cervical alignment [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
    Radiologic evaluation of the global cervical alignment

  • disc height [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
    Radiologic evaluation of the disc height of the operated level(s)

  • Radiologic adverse events [ Time Frame: Preop, 3M, 12M and 24M ] [ Designated as safety issue: No ]
    Radiologic evaluation of adverse events such as migration, subsidence


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Radiculopathy Cervical
Radiculopathy, Cervical
Device: Cervical arthroplasty surgery with Granvia-C
Discectomy and Cervical arthroplasty according to standard practice of the surgeon

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

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with Cervicobrachial neuralgia due to symptomatic cervical discopathy

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518582

Locations
Belgium
CHR Namur Recruiting
Namur, Belgium, 5000
Contact: Milbouw, MD       germain.milbouw@chr-namur.be   
Principal Investigator: Milbouw, MD         
France
Tripode Hospital Recruiting
Bordeaux, France, 33000
Contact: Guérin, MD       pguerin_patrick@yahoo.fr   
Principal Investigator: Guérin, MD         
Clairval hospital Recruiting
Marseille, France, 13009
Contact: Barat, MD       jlbarat1@yahoo.fr   
Principal Investigator: Barat, MD         
Sponsors and Collaborators
Medicrea International
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 CHU Bordeaux, France
  More Information

No publications provided

Responsible Party: Medicrea International
ClinicalTrials.gov Identifier: NCT01518582     History of Changes
Other Study ID Numbers: #0802
Study First Received: January 5, 2012
Last Updated: September 11, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins

Keywords provided by Medicrea International:
Cervicobrachial
neuralgia
symptomatic cervical discopathy

Additional relevant MeSH terms:
Brachial Plexus Neuritis
Brachial Plexus Neuropathies
Neuralgia
Intervertebral Disk Degeneration
Intervertebral Disk Displacement
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuritis
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014