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Clinical Trials in France / NCT05003414
Active, not recruiting Observational

The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

NCT05003414 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2020-01-14
Last updated
2025-09-29

Condition(s) studied

ArthritisTraumatic ArthritisRheumatoid ArthritisPoly-arthritisAvascular Necrosis

Investigational drug(s) / intervention(s)

GMK Sphere cementless Knee Replacement

GMK Sphere cementless Knee Replacement: Performance of Total Knee Arthroplasty (TKA) with GMK Sphere cementless Knee Replacement

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Clinique Saint Vincent de Paul Bourgoin France
Clinique du Parc Caen France
Hôpitaux Civils de Colmar Colmar France
Clinique des Acacias Cucq France
Hôpital de la Tour Meyrin Switzerland

More Medacta International SA trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05003414 on ClinicalTrials.gov ↗ ← All trials in France