The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

Last updated: March 14, 2023
Sponsor: Medacta International SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT05003414
P02.014.26
  • Ages 18-80
  • All Genders

Study Summary

This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A disabled or severely disabled joint as a result of arthritis, traumatic arthritis,rheumatoid arthritis, poly-arthritis or avascular necrosis
  • Patients between the age of 18 and 80 at the time of consent
  • Listed for total knee replacement surgery.
  • Patients who are willing and able to give informed written consent

Exclusion

Exclusion Criteria:

  • Progressive local or systemic infection
  • Muscular loss, neuromuscular disease or vascular deficiency of the affected limb,making the operation unjustifiable
  • Severe instability secondary to advance destruction of condralar structures or loss ofintegrity of the medial or lateral ligament
  • Those whose prospects for a recovery to independent mobility would be compromised byknown coexistent, medical problems
  • Patient whose BMI exceeds 40
  • Any case not described in the inclusion criteria

Study Design

Total Participants: 200
Study Start date:
January 14, 2020
Estimated Completion Date:
December 31, 2032

Connect with a study center

  • Clinique Saint Vincent de Paul

    Bourgoin-Jallieu, 38300
    France

    Active - Recruiting

  • Clinique du Parc

    Caen, 14000
    France

    Active - Recruiting

  • Hôpitaux Civils de Colmar

    Colmar, 68000
    France

    Site Not Available

  • Clinique des Acacias

    Cucq, 62780
    France

    Site Not Available

  • Hôpital de la Tour

    Meyrin, CH-1217
    Switzerland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.