Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 531
- 试验地点
- 1
- 主要终点
- Noise nuisance
研究概览
简要总结
Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem.
Retrospective and prospective multicentric study.
详细描述
On a series of patients operated on for more than two years after a total hip arthroplasty that resulted in the implantation of a ceramic-on-ceramic prosthesis with a customized femoral stem:
Primary objective: To assess the frequency of occurrence of joint noise.
Secondary objectives:
- To describe the characteristics of the noise nuisance (date of onset, frequency, intensity, impact...)
- To evaluate the individual and surgical factors associated with the occurrence of noise pollution.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years or older, who has been informed of the research
- •Patient who has had a fourth generation ceramic/ceramic hip replacement implanted for at least two years as a first-line replacement
- •Patient who has had a three-dimensional preoperative examination leading to the design and implantation of a custom femoral stem
- •Patient regularly monitored since surgery and for whom all clinical and radiological data are available at the three-month and two-year follow-up visits
排除标准
- •Patient operated for revision
- •Patient under legal protection, guardianship or curators
- •Patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)
结局指标
主要结局
Noise nuisance
时间窗: 2 years
Percentage of occurrence of noise nuisance (assessed in relation to the total number of patients and the total number of prostheses). The frequency of occurrence of noise nuisance will be analysed descriptively. The time elapsed until the occurrence of the noise nuisance will be additionally assessed by a Kaplan-Meier analysis.
次要结局
- Prosthesis life span(2 years)
- Hip disability and Osteoarthritis Outcome Score (HOOS) Score(2 years)
- Forgotten Joint Score(2 years)
- Oxford Score(2 years)