NCT05459948 The Medacta GMK SpheriKA Post-Marketing Surveillance Study
| NCT ID | NCT05459948 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medacta International SA |
| Condition | Arthropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 281 participants |
| Start Date | 2022-07-30 |
| Primary Completion | 2035-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 281 participants in total. It began in 2022-07-30 with a primary completion date of 2035-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05459948 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Arthropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05459948 currently recruiting?
Yes, NCT05459948 is actively recruiting participants. Contact the research team at girardi@medacta.ch for enrollment information.
Where is the NCT05459948 trial being conducted?
This trial is being conducted at Mérignac, France, Saint-Jean, France, Bergamo, Italy, Winterthur, Switzerland.
Who is sponsoring the NCT05459948 clinical trial?
NCT05459948 is sponsored by Medacta International SA. The trial plans to enroll 281 participants.