NCT02199600Active, not recruiting
The Medacta International GMK Sphere Post-Marketing Surveillance Study
Source: ClinicalTrials.gov · Last updated 16 Dec 2024
Brief summary (registry, in English)
This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 7 Jul 2014
- Start date
- 1 Oct 2012
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Medacta International SA
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT02199600
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 1 Oct 2012 to the primary completion date, 31 Oct 2029
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Progressive local or systemic infection
- Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Maria Middelares Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| The Elective Orthopaedic Centre (EOC) Coordinator of this site? Confirm its status | Epsom | United Kingdom | Unknown status |
| Royal National Orthopaedic Hospital NHS Trust Coordinator of this site? Confirm its status | Stanmore | United Kingdom | Unknown status |
| Royal London Hospital Coordinator of this site? Confirm its status | Whitechapel | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.