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

NCT07382050 | Not Yet Recruiting DMC

• 1 other identifier: M20251018
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

THA; Prosthesis

Keywords

total hip arthroplasty; Zirconia ceramic prosthesis; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Harris score

  The patient returned to the outpatient department for a follow-up visit, and the scale was followed up

  Six months

Secondary Outcomes (4)

• FJS score

  Six months

• operation time

  Perioperative/Periprocedural

• WOMAC

  Six months

• AE/SAE and postoperative complications

  through study completion, an average of 1 year

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• There are contraindications for hip replacement surgery
• It is known that the patient has a history of allergy to one or more implant materials
• Pregnant or lactating women
• Hip dysplasia is classified into CROWE grades 3 and 4
• 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
• The reasons why other researchers believe that patients are not suitable for this study

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking Union Medical College Hospital: collaborator
• Peking University First Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Peking University Shougang Hospital: collaborator
• Peking University People's Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)