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Active, not recruiting Not applicable

The Medacta International GMK Sphere Post-Marketing Surveillance Study

NCT02199600 · tracked via the Priya Life Science UK tracker
Phase
Not applicable
Started
2012-10
Last updated
2024-12-16

Condition(s) studied

ArthritisTraumatic ArthritisRheumatoid ArthritisPoly-arthritisAvascular Necrosis

Investigational drug(s) / intervention(s)

GMK Sphere Knee Replacement

Study summary

This is a Post-Marketing Surveillance of GMK Sphere 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 must be between the age of 18 and 80 at the time of consent * Listed for total knee replacement surgery. * Patients who are willing 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 condylar structures or loss of integrity of the medial or lateral ligament * Any patient who cannot or will not provide informed consent for participation in the study * 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)

  • Assessment of the clinical outcome following total knee replacement using the Knee Society Score. — 6 months

Trial sites (4)

FacilityCityRegionStatus
AZ Maria Middelares Ghent Belgium
Royal London Hospital Whitechapel London
Royal National Orthopaedic Hospital NHS Trust Stanmore Middlesex
The Elective Orthopaedic Centre (EOC) Epsom Surrey
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 NCT02199600 on ClinicalTrials.gov ↗ ← All trials in the UK