GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study

NCT01518582 | Completed

• 1 other identifier: #0802
• Study Type: observational
• Target: 70
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cervicobrachial Neuralgia; Cervical Discopathy

Keywords

Cervicobrachial; neuralgia; symptomatic cervical discopathy

Outcome Measures

Primary Outcomes (1)

• Composite criterion of success

  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 Outcomes (8)

• Radiologic evaluation of the motion

  Preop, 3M, 12M and 24M

• Evaluation of potential peri and post-operative adverse events related or not to prosthesis.

  preop, 3M, 12M, 24M

• Evaluation of satisfaction

  Preop, 3M, 12M and 24M

• Evaluation of the time to return to activities (normal activity, work, sport activity)

  preop, 3M, 12M, 24M

• Evaluation of Pain

  Preop, 3M, 12M and 24M

Study Arms (1)

Radiculopathy Cervical

Radiculopathy, Cervical

Device: Cervical arthroplasty surgery with Granvia-C

Interventions

Cervical arthroplasty surgery with Granvia-C DEVICE

Discectomy and Cervical arthroplasty according to standard practice of the surgeon

Radiculopathy Cervical

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

People with Cervicobrachial neuralgia due to symptomatic cervical discopathy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medicrea International: lead

Study Sites (3)

CHR Namur

Namur, 5000, Belgium

Location

Tripode Hospital

Bordeaux, 33000, France

Location

Clairval hospital

Marseille, 13009, France

Location

MeSH Terms

Conditions

Brachial Plexus Neuritis; Neuralgia

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuritis; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 26, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

BE (1); FR (2)