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

Peking University

Status: Not yet enrolling

Conditions: THA; Prosthesis

Study type: Observational

Funder types: Other

Identifiers

NCT07382050

M20251018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient's age ranges from 18 to 80 years old (inclusive), with no gender restrictions.
2. The patient's bones have matured.
3. The patient is indicated for hip replacement surgery
4. The subjects participating in the study were undergoing hip replacement for the first time
5. The subject or his/her guardian is willing and able to sign the informed consent form

Exclusion criteria

1. There are contraindications for hip replacement surgery
2. It is known that the patient has a history of allergy to one or more implant materials
3. Pregnant or lactating women
4. Hip dysplasia is classified into CROWE grades 3 and 4
5. Those who are physically weak or unable to tolerate surgery due to other systemic diseases, as well as those with an expected lifespan of less than two years
6. The reasons why other researchers believe that patients are not suitable for this study

Trial design

290 participants in 1 patient group

Received the hip joint prosthesis system implanted by Beijing Anthrone Technology Co., Ltd.