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

A Prospective Multicenter Clinical Study on the Efficacy and Safety of the Zirconia Ceramic Hip Joint Prosthesis System After Its Market launchM20251018

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prosthesis; THA

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 290

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
      • Contact: Yuhang Zheng, MD; Phone Number: 010-18811185091; Email: zhengyuhang0723@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris score	The patient returned to the outpatient department for a follow-up visit, and the scale was followed up	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FJS score	The patient returned to the outpatient department for a follow-up visit, and the scale was followed up	Six months
operation time	Measure the time from the moment the knife touches the skin to the completion of the surgical incision suture	Perioperative/Periprocedural
WOMAC	he patient returned to the outpatient department for a follow-up visit, and the scale was followed up	Six months
AE/SAE and postoperative complications	Describe the number and frequency of various adverse events, adverse events related to the study product, adverse events leading to dropout, and serious adverse events. Describe the number and frequency of various complications and complications related to the study product. Provide corresponding lists for adverse events and complications. Calculate the survival rate of the prosthesis.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Peking University First Hospital; Peking University People's Hospital; Beijing Friendship Hospital; Peking Union Medical College Hospital; Peking University Shougang Hospital; China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: safety; total hip arthroplasty; efficacy; Zirconia ceramic prosthesis
• Other Study ID Numbers: M20251018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be published in the form of an academic paper.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No