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The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

NCT05003414

Active Not RecruitingN/A

Sponsor: Medacta International SA

Conditions: Arthritis, Traumatic Arthritis, Rheumatoid Arthritis, Poly-arthritis, Avascular Necrosis

Interventions: GMK Sphere cementless Knee Replacement

Countries: France, Switzerland

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

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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 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 of integrity of the medial or lateral ligament
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
* Patient whose BMI exceeds 40
* Any case not described in the inclusion criteria

Locations (5)

Bourgoin, France
Caen, France
Colmar, France
Cucq, France
Meyrin, Switzerland