A Prospective Multicenter Clinical Study on the Efficacy... | NCT07382050

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

NCT07382050

Sponsor

Peking University Third Hospital

Status

Not yet recruiting

Last Update Posted

Feb 2, 2026Actual

Enrollment

290Estimated

Phase

Not provided

Conditions

THA
Prosthesis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jan 12, 2026

First Submission Date that Met QC Criteria

Jan 25, 2026

First Posted Date

Feb 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2026

Last Update Posted Date

Feb 2, 2026Actual

Name	Class
Peking Union Medical College Hospital	OTHER
Peking University First Hospital	OTHER
Beijing Friendship Hospital	OTHER
China-Japan Friendship Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

290Estimated

Label	Type	Description	Intervention Names
Received the hip joint prosthesis system implanted by Beijing Anthrone Technology Co., Ltd.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing	Beijing Municipality	100191	China

IPD Sharing Statement Module

Plan to Share IPD

Description

The data will be published in the form of an academic paper.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided