Monitoring the performance of the GMK SpheriKA knee prosthesis
Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study
This study is testing how well the GMK SpheriKA knee prosthesis works for people getting a total knee replacement and how it helps them recover after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 281 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 4 sites (Mérignac and 3 other locations) |
| Trial ID | NCT05459948 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect clinical and radiological data to evaluate the performance of the GMK SpheriKA knee prosthesis, which is implanted using a kinematic alignment technique. Participants will be monitored postoperatively to assess their recovery and the effectiveness of the prosthesis. The study will involve patients who are undergoing primary total knee replacement and will require their compliance with follow-up evaluations and weight-bearing restrictions.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 to 80 who require a primary total knee replacement and have intact collateral ligaments.
Not a fit: Patients with inflammatory arthritis, morbid obesity, or previous knee surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term performance and safety of the GMK SpheriKA knee prosthesis, potentially improving outcomes for knee replacement patients.
How similar studies have performed: Other studies on knee prosthesis performance have shown success, indicating that post-marketing surveillance can provide critical data for improving surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients willing to sign the informed consent. * Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations. * Patients 18 - 80 years of age at the time of surgery. * Patients requiring a primary total knee replacement (on label use). * Patients with intact collateral ligaments. Exclusion Criteria: * Patients with inflammatory arthritis. * Morbidly obese patients, with a body mass index (BMI) \> 40. * Patients with a history of total or unicompartmental reconstruction of the affected joint. * Patients that have had a high tibial osteotomy or femoral osteotomy. * Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * Patients with a systemic or metabolic disorder leading to progressive bone deterioration. * Patients that are immunologically compromised or receiving chronic steroids (\> 30 days). * Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and/or fixation to the prosthesis. * Patients with an active or suspected latent infection in or surrounding the knee joint. * Pregnant or breastfeeding women.
Where this trial is running
Mérignac and 3 other locations
- Centre de l'Arthrose — Mérignac, France (Recruiting)
- Clinique de l'Union — Saint-Jean, France (Recruiting)
- Humanitas Castelli — Bergamo, Italy (Recruiting)
- Gelenkzentrum Winterthur — Winterthur, Switzerland (Recruiting)
Study contacts
- Study coordinator: Arianna Girardi
- Email: girardi@medacta.ch
- Phone: +41 91 696 60 60
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.