Prosthesis, THA
Conditions
Keywords
total hip arthroplasty, Zirconia ceramic prosthesis, efficacy, safety
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.
Interventions
None listed
Sponsors
Peking University Third Hospital
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 design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
1. There are contraindications for hip replacement surgery 2. It is known that the patient has a history of allergy to one or more implant materials 3. Pregnant or lactating women 4. Hip dysplasia is classified into CROWE grades 3 and 4 5. 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 6. The reasons why other researchers believe that patients are not suitable for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris score | Six months | The patient returned to the outpatient department for a follow-up visit, and the scale was followed up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FJS score | Six months | The patient returned to the outpatient department for a follow-up visit, and the scale was followed up |
| operation time | Perioperative/Periprocedural | Measure the time from the moment the knife touches the skin to the completion of the surgical incision suture |
| WOMAC | Six months | he patient returned to the outpatient department for a follow-up visit, and the scale was followed up |
| AE/SAE and postoperative complications | 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. |
Countries
China
Outcome results
None listed