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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).
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Peking University Third Hospital
Beijing, Beijing Municipality, China
Start Date
September 8, 2022
Primary Completion Date
February 2, 2023
Completion Date
May 13, 2024
Last Updated
October 15, 2024
144
ACTUAL participants
robotic-assisted TKA
PROCEDURE
CI-TKA
PROCEDURE
Lead Sponsor
Peking University Third Hospital
NCT06809998
NCT07302724
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