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

NCT07382050 · tracked via the Priya Life Science China tracker

Sponsor

Peking University Third Hospital

Phase

Observational

Started

2026-01-01

Last updated

2026-02-02

Condition(s) studied

THAProsthesis

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

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

Primary outcome measure(s)

Harris score — Six months
The patient returned to the outpatient department for a follow-up visit, and the scale was followed up

Trial sites (1)

Facility	City	Region	Status
Peking University Third Hospital	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07382050 on ClinicalTrials.gov ↗ ← All trials in China