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NCT Number: NCT07382050

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

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.

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Key information

Conditions

THA Prosthesis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Harris score

    Time frame: Six months

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

Secondary outcomes

  1. FJS score

    Time frame: Six months

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

  2. operation time

    Time frame: Perioperative/Periprocedural

    Measure the time from the moment the knife touches the skin to the completion of the surgical incision suture

  3. WOMAC

    Time frame: Six months

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

  4. AE/SAE and postoperative complications

    Time frame: through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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