RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques
Rationale for conducting the study: The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially lead
| Condition(s) | Knee Arthroplasty, Total, Robotic-assisted, Osteoarthritis of the Knee |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Rationale for conducting the study: The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events. Study design: M |
| Who can participate | Inclusion Criteria: * Adults aged 18 years and older. * Eligible for TKR according to local guidelines and routines. * Willingness to participate in the study. Exclusion Criteria: * Patients with extreme malalignment necessitating special implants or techniques. * Patients unfit for surgery due to other medical reasons. * Patients who, for other reason such as alcohol or substance abuse, is deemed unsuitable to participate in the study. * Patients who, for other reasons can't fulfill the required patient recorded outcome measures |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Danderyd Hospital |
| Locations | Stockholm, Sweden |
| Start date | 2024-03-04 |
| NCT ID | NCT06389435 |
| Official listing | https://clinicaltrials.gov/study/NCT06389435 |