NCT05003414Active, not recruiting
The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study
A Prospective, Multicentre, International, Post-marketing, Longitudinal, Observational Cohort Study to Monitor the Performances of GMK Sphere Cementless Knee Prosthesis
Source: ClinicalTrials.gov · Last updated 29 Sept 2025
Brief summary (registry, in English)
This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 6 Aug 2021
- Start date
- 14 Jan 2020
- Primary completion date
- 31 Jan 2030
- Lead sponsor
- Medacta International SA
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05003414
What you commit to
- Study type: Observational
- Planned participants: 200
- From 14 Jan 2020 to the primary completion date, 31 Jan 2030
- 5 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 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
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 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital de La Tour Coordinator of this site? Confirm its status | Meyrin | Switzerland | Unknown status |
| Clinique Saint Vincent de Paul Coordinator of this site? Confirm its status | Bourgoin | France | Unknown status |
| Clinique du Parc Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Hôpitaux Civils de Colmar Coordinator of this site? Confirm its status | Colmar | France | Unknown status |
| Clinique des Acacias Coordinator of this site? Confirm its status | Cucq | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.