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.
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
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
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
Cohort
Prospective
Not listed
Harris score
The patient returned to the outpatient department for a follow-up visit, and the scale was followed up
FJS score
The patient returned to the outpatient department for a follow-up visit, and the scale was followed up
operation time
Measure the time from the moment the knife touches the skin to the completion of the surgical incision suture
WOMAC
he patient returned to the outpatient department for a follow-up visit, and the scale was followed up
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.
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Peking University Third Hospital
Lead sponsor
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
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