NCT06638047

Early Clinical and Radiological Outcomes of a Novel Robotic TKA System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Total Knee Anthroplasty
• Robotic Surgery

Interventions

Type	Name	Description
PROCEDURE	robotic-assisted TKA	Robotic-assisted TKA means that TKA surgery is operated with the guidance of robotic system.
PROCEDURE	CI-TKA	TKA operated with conventional instruments

Timeline

• Start date: 2022-09-08
• Primary completion: 2023-02-02
• Completion: 2024-05-13
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: China