Status:
ACTIVE_NOT_RECRUITING
The Medacta International GMK Sphere Post-Marketing Surveillance Study
Lead Sponsor:
Medacta International SA
Conditions:
Arthritis
Traumatic Arthritis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.
Detailed Description
The clinical performance of the GMK® Sphere, manufactured by Medacta International, will be evaluated by a multicentre, prospective clinical surveillance study. The Elective Orthopaedic Centre (EOC),...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02199600
Start Date
October 1 2012
End Date
October 1 2029
Last Update
December 16 2024
Active Locations (4)
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1
AZ Maria Middelares
Ghent, Belgium, 9000
2
Royal London Hospital
Whitechapel, London, United Kingdom, E11BB
3
Royal National Orthopaedic Hospital NHS Trust
Stanmore, Middlesex, United Kingdom, HA74LP
4
The Elective Orthopaedic Centre (EOC)
Epsom, Surrey, United Kingdom, KT18 7EG