Finished
Early Clinical and Radiological Outcomes of a Novel Robotic TKA System
NCT06638047 · Peking University Third Hospital · Updated 15 Oct 2024
- What is being tested
- robotic-assisted TKA; CI-TKA
- For
- Total Knee Anthroplasty; Robotic Surgery
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 85 years. About 144 people. The full rules are on the registry page.
- Where
- China
- When
- Starts or started 8 Sept 2022, ends 13 May 2024. Registered 15 Oct 2024.
- Results
- None posted yet.
In the researchers' words
This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system. 144 patients undergoing primary TKA were enrolled in this prospective, multicenter RCT conducted in 3 hospitals. The primary outcome was the rate of patients whose postoperative alignment was less than 3° deviated from the planned evaluated by full-length weight-bearing X-rays of the lower limb at 12 weeks postoperatively. Secondary outcomes will include coronal and sagittal alignment of the components, operation times, blood loss, 12-week range of motion(ROM), 12-week postoperative functional outcomes and satisfaction evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events (AEs).
Sites
- Peking University Third HospitalBeijing, Beijing Municipality, China
