Post-marketing surveillance of a cementless knee prosthesis
A Prospective, Multicentre, International, Post-marketing, Longitudinal, Observational Cohort Study to Monitor the Performances of GMK Sphere Cementless Knee Prosthesis
This study looks at how well the GMK Sphere cementless knee replacement works for people with severe joint problems, like arthritis, after they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 5 sites (Bourgoin-Jallieu and 4 other locations) |
| Trial ID | NCT05003414 on ClinicalTrials.gov |
What this trial studies
This observational study monitors the performance and outcomes of the GMK Sphere cementless knee prosthesis in patients undergoing total knee replacement. It focuses on individuals with severe joint disabilities due to conditions such as arthritis and avascular necrosis. The study aims to gather real-world data on the safety and effectiveness of this specific knee replacement device post-approval. Participants will be followed to assess their recovery and mobility improvements after surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with severe joint disabilities due to arthritis or related conditions who are listed for total knee replacement surgery.
Not a fit: Patients with severe comorbidities, infections, or those whose BMI exceeds 40 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the GMK Sphere knee prosthesis, potentially improving patient outcomes.
How similar studies have performed: Other post-marketing surveillance studies of orthopedic devices have shown success in monitoring long-term outcomes, suggesting this approach is validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 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
Where this trial is running
Bourgoin-Jallieu and 4 other locations
- Clinique Saint Vincent de Paul — Bourgoin-Jallieu, France (Recruiting)
- Clinique du Parc — Caen, France (Recruiting)
- Hôpitaux Civils de Colmar — Colmar, France (Not_yet_recruiting)
- Clinique des Acacias — Cucq, France (Not_yet_recruiting)
- Hôpital de la Tour — Meyrin, Switzerland (Recruiting)
Study contacts
- Principal investigator: Emmanuel Marchetti, MD — Clinique Saint Vincent de Paul
- Study coordinator: Denise Falcone
- Email: falcone@medacta.ch
- Phone: +41916966060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.