Polyethylene Wear Particle Analysis of Total Hip Arthroplasty -International Multicenter Study-
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Equivalent circle diameter of polyethylene wear particles
研究概览
简要总结
Purpose of research The purpose of this study was to demonstrate that polyethylene (Vitamin E-containing polyethylene), a newly introduced biomaterial for tibial inserts in hip replacement surgery and widely used clinically, but whose mid- to long-term clinical results are still unknown, is superior to conventional polyethylene in vivo. The aim of this project is to conduct an international multi-center joint research study to determine whether polyethylene wear debris production can be reduced in the future, using an in vivo polyethylene wear debris analysis method that the investigators developed as a method that can provide early feedback.
详细描述
Research method In this study, the investigators conducted the following steps to determine the in vivo wear particles (number, size, and morphology) of conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose mid- to long-term results have not yet been clarified. Clarifying the difference.
Target of this research In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment.
First total joint replacement
- 30 patients using polyethylene containing Vitamin E
- 30 patients using conventional polyethylene (no high cross-linking)
- 30 patients using conventional polyethylene (with high cross-linking)
Accumulation of periarticular tissue In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing revision hip arthroplasty within the study period
- •Patients over 20 years old
- •Patients who have received a sufficient explanation, have sufficient understanding, and have given their free written consent.
- •Patients who have passed 2 years or more since their first total hip arthroplasty
排除标准
- •Patients who are judged to be unsuitable as research subjects by the research physician
结局指标
主要结局
Equivalent circle diameter of polyethylene wear particles
时间窗: When tissue sample was collected during THA revision surgery
equivalent circle diameter \[㎛\]
Aspect ratio of polyethylene wear particles
时间窗: When tissue sample was collected during THA revision surgery
aspect ratio
Number of polyethylene wear particles
时间窗: When tissue sample was collected during THA revision surgery
counts / g (tissue sample)
Roundness of polyethylene wear particles
时间窗: When tissue sample was collected during THA revision surgery
roundness
次要结局
- Hip dysfunction and Osteoarthritis Outcome. Score for Joint Replacement(When tissue sample was collected during THA revision surgery)
- Hip joint adduction angle(When tissue sample was collected during THA revision surgery)
- Body mass index(When tissue sample was collected during THA revision surgery)
- Hip joint flexion angle(When tissue sample was collected during THA revision surgery)
- Hip joint exertion angle(When tissue sample was collected during THA revision surgery)
- Hip joint abduction angle(When tissue sample was collected during THA revision surgery)
- Harris Hip Score(When tissue sample was collected during THA revision surgery)
- University of California at Los Angeles activity score(When tissue sample was collected during THA revision surgery)
研究者
Yukihide Minoda
Associate Professor
Osaka Metropolitan University