Clinical Trials in the UK / NCT02199600
Active, not recruiting
Not applicable
The Medacta International GMK Sphere Post-Marketing Surveillance Study
NCT02199600 · tracked via the Priya Life Science UK tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Medacta International SA trials in the UK
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 NCT02199600 on ClinicalTrials.gov ↗ ← All trials in the UK