Clinical Trial

A Prospective Multicenter Clinical Study on the Efficacy and Safety of the Zirconia Ceramic Hip Joint Prosthesis System After Its Market Launch

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Summary
This study adopted a prospective, multi-center, single-group target value trial design to evaluate the safety and efficacy of the hip joint prosthesis system produced by Beijing Anshou Technology Co., Ltd. in total hip arthroplasty. This clinical study selected seven clinical centers and recruited 290 subjects. Each center competed for enrollment, with the requirement that each center should undertake no less than 8 cases and no more than half of the total cases. The enrollment stopped when the total number of cases met the design requirements. After the patients signed the informed consent form, they entered the screening process. After the screening was successful, the hip joint prosthesis system produced by Beijing Anshou Technology Co., Ltd. was implanted, and follow-up was conducted for the patients at "before surgery, on the day of surgery, immediately after surgery until discharge, 2 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery." The demographic information and various evaluation indicators of the subjects were collected.
Trial Details
NCT Number NCT07382050
Lead Sponsor Peking University Third Hospital
Collaborators: Peking Union Medical College Hospital, Peking University First Hospital, Beijing Friendship Hospital, China-Japan Friendship Hospital, Peking University Shougang Hospital, Peking University People's Hospital
Conditions THA, Prosthesis
Enrollment 290 participants
Start Date 2026-01-01
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-02