THANCT07382050
A Prospective Multicenter Clinical Study on the Efficacy and Safety of the Zirconia Ceramic Hip Joint Prosthesis System After Its Market Launch
An observational study of THA and Prosthesis, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- THA, Prosthesis
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yuhang Zheng, MD, 010-18811185091, zhengyuhang0723@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- THA, Prosthesis
- Keywords
- total hip arthroplasty, Zirconia ceramic prosthesis, efficacy, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Received the hip joint prosthesis system implanted by Beijing Anthrone Technology Co., Ltd. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris score
The patient returned to the outpatient department for a follow-up visit, and the scale was followed up
Measured: Six months
Secondary outcomes (4)
FJS score
The patient returned to the outpatient department for a follow-up visit, and the scale was followed up
Measured: Six months
operation time
Measure the time from the moment the knife touches the skin to the completion of the surgical incision suture
Measured: Perioperative/Periprocedural
WOMAC
he patient returned to the outpatient department for a follow-up visit, and the scale was followed up
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University First Hospital, Beijing Friendship Hospital, China-Japan Friendship Hospital, Peking University Shougang Hospital, Peking University People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382050
- Sponsor's protocol ID
- M20251018
- Status last verified
- Dec 2025
- First submitted
- 12 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be published in the form of an academic paper.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Clinical Study on the Efficacy and Safety of the Zirconia Ceramic Hip Joint Prosthesis System After Its Market launchM20251018
- ClinicalTrials.gov ID
- NCT07382050
- Acronym / sponsor ID
- M20251018
- Conditions
- THA, Prosthesis
- Keywords
- total hip arthroplasty, Zirconia ceramic prosthesis, efficacy, safety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University First Hospital, Beijing Friendship Hospital, China-Japan Friendship Hospital, Peking University Shougang Hospital, Peking University People's Hospital
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Received the hip joint prosthesis system implanted by Beijing Anthrone Technology Co., Ltd. | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Harris score
Time frame: Six months
The patient returned to the outpatient department for a follow-up visit, and the scale was followed up
4 secondary outcomes
FJS score
Time frame: Six months
operation time
Time frame: Perioperative/Periprocedural
WOMAC
Time frame: Six months
AE/SAE and postoperative complications
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No. The data will be published in the form of an academic paper.
Related trials for THA
RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium Tuberculosis
Enrolling by invitationPhase 2
Efficacy of Intravenous Oxytocin to Speed Recovery After THA
Total Hip Arthroplasty
Active, not recruitingObservational study
Thailand Birth and Infant Outcomes Study
Outcome Assessment
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of THA and Prosthesis, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris score (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.