Not recruiting yet
RSA Restoris MultiCompartmental Knee
NCT05417984 · Reinier Haga Orthopedisch Centrum · Updated 14 June 2022
- What is being tested
- Restoris MCK
- For
- Osteoarthritis, Knee
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 33 people. The full rules are on the registry page.
- Where
- Not stated
- When
- Starts or started June 2022, ends June 2029. Registered 14 June 2022.
- Results
- None posted yet.
In the researchers' words
Patients with isolated medial compartment arthritis of the knee are commonly treated with unicompartmental knee arthroplasty (UKA). In contrast with total knee arthroplasty (TKA), UKA shows a higher revision rate, which might be due to implant malpositioning and postoperative malalignment of the lower limb and incorrect soft tissue balancing. Nowadays, robotic-assisted UKA is used which improves accurate positioning, optimizes soft-tissue balancing and optimizes radiographic alignment of the implant. The potential benefit could be that this better alignment and positioning results in improved functional outcome and long-term survivorship. As there is a lack in long-term results, more research is needed to the long-term results of robotic-assisted UKA. As long-term results are related to early migration of the implant, investigating the early migration will have additional value to predict the long-term results of robotic-assisted UKA. In this study, we will investigate the early migration of a unicompartmental knee implant (Restoris MultiCompartmental Knee Implant System (Restoris MCK)) used in robotic-assisted UKA using model-based roentgen stereogrammetric analysis (mRSA) and we will relate the migration of this implant to the long-term results of the implant. The primary objective is to assess the fixation and migration patterns of the Restoris MutliCompartmental Knee…