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GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study

NCT01518582 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2016-06-28

No results posted yet for this study

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

Interventions

DEVICE

Cervical arthroplasty surgery with Granvia-C

Discectomy and Cervical arthroplasty according to standard practice of the surgeon

Sponsors & Collaborators

  • Medicrea International

    lead INDUSTRY

Principal Investigators

  • John Yeh, MD · Royal London Hospital, UK

  • Frédéric Schils, MD · CHC Liège, Belgium

  • Hans Meisel, MD · Halle Klinike, Germany

  • Patrick Guérin, MD · University Hospital, Bordeaux

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01518582 on ClinicalTrials.gov