The Medacta GMK SpheriKA Post-Marketing Surveillance Study
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
| Condition(s) | Arthropathy, Knee Replacement |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis. |
| Who can participate | 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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Medacta International SA |
| Locations | Mérignac, France; Saint-Jean, France; Bergamo, Italy; Winterthur, Switzerland |
| Start date | 2022-07-30 |
| NCT ID | NCT05459948 |
| Official listing | https://clinicaltrials.gov/study/NCT05459948 |