The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

Last updated: September 23, 2025
Sponsor: Medacta International SA
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Treatment

GMK Sphere cementless Knee Replacement

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 lossof integrity 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
Treatment Group(s): 1
Primary Treatment: GMK Sphere cementless Knee Replacement
Phase:
Study Start date:
January 14, 2020
Estimated Completion Date:
December 31, 2032

Connect with a study center

  • Clinique Saint Vincent de Paul

    Bourgoin 3030960, 38300
    France

    Site Not Available

  • Clinique Saint Vincent de Paul

    Bourgoin-Jallieu, 38300
    France

    Site Not Available

  • Clinique du Parc

    Caen, 14000
    France

    Site Not Available

  • Clinique du Parc

    Caen 3029241, 14000
    France

    Site Not Available

  • Hôpitaux Civils de Colmar

    Colmar, 68000
    France

    Site Not Available

  • Hôpitaux Civils de Colmar

    Colmar 3024297, 68000
    France

    Site Not Available

  • Clinique des Acacias

    Cucq, 62780
    France

    Site Not Available

  • Clinique des Acacias

    Cucq 3022167, 62780
    France

    Site Not Available

  • Hôpital de la Tour

    Meyrin, CH-1217
    Switzerland

    Site Not Available

  • Hôpital de la Tour

    Meyrin 2659667, CH-1217
    Switzerland

    Site Not Available

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