A Prospective Multicenter Clinical Study on the Efficacy and Safety of the Zirconia Ceramic Hip Joint Prosthesis System After Its Market launchM20251018
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Harris score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Received the hip joint prosthesis system implanted by Beijing Anthrone Technology Co., Ltd.
结局指标
主要结局
Harris score
时间窗: Six months
The patient returned to the outpatient department for a follow-up visit, and the scale was followed up
次要结局
- FJS score(Six months)
- operation time(Perioperative/Periprocedural)
- WOMAC(Six months)
- AE/SAE and postoperative complications(through study completion, an average of 1 year)