A Prospective Multicenter Clinical Study on the Efficacy and Safety of the Zirconia Ceramic Hip Joint Prosthesis System After Its Market launchM20251018
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 290
- Locations
- 1
- Primary Endpoint
- Harris score
Overview
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
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Received the hip joint prosthesis system implanted by Beijing Anthrone Technology Co., Ltd.
Outcomes
Primary Outcomes
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
- FJS score(Six months)
- operation time(Perioperative/Periprocedural)
- WOMAC(Six months)
- AE/SAE and postoperative complications(through study completion, an average of 1 year)