Polyethylene Wear Particle Analysis of Total Knee Arthroplasty -International Multicenter Study-
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of polyethylene wear particles
研究概览
简要总结
The purpose of this study was to investigate whether polyethylene (Vitamin E-containing polyethylene), which has been newly introduced and widely used clinically as a biomaterial for tibial inserts in total knee arthroplasty, but whose mid- to long-term clinical results are still unknown, is more effective than conventional polyethylene.
Our goal is to clarify through an international multi-center joint study using in vivo polyethylene wear particle analysis, which the investigators developed as a method to provide early feedback, as to whether polyethylene wear debris production in vivo can be reduced.
详细描述
Anticipated medical contribution and significance In this study, the investigators investigate whether a newly introduced polyethylene (highly cross-linked polyethylene, vitamin E-containing polyethylene in vivo) can suppress wear debris production more than conventional polyethylene. If the newly introduced polyethylene can reduce wear debris production, it is expected to reduce failure of artificial joints in the future. However, if newly introduced polyethylene is actually increasing wear debris production, it could be an early alarm bell for surgeons around the world. In other words, the international and social impact of this research is extremely large.
Two unique requirements are necessary to carry out this research. Firstly, in vivo analysis of polyethylene wear particles is possible, and secondly, the number of surgical cases of revision knee arthroplasty targeted for investigation is large. The first requirement is that the applicants have published many English-language papers on in vivo polyethylene wear debris analysis, and that their facilities are the most suitable and fully capable of carrying out the analysis worldwide. be. The second requirement is that the investigators need to collaborate not only with our hospital but also with facilities that perform a large number of revision knee arthroplasty surgeries. Not only our hospital, but also our affiliated hospital, which is one of the facilities in Japan that performs the most knee joint surgeries (Naniwa Ikuno Hospital), and the hospital that performs the most knee joint surgeries worldwide (Mayo Clinic [USA]). , Hospital for Special Surgery [USA], Istituto Ortopedico Rizzoli [Italy]).
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 [Figure 3].
Target of this research In this study, the investigators will focus on patients undergoing revision knee arthroplasty as a routine medical treatment.
First total joint replacement
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 knee 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 knee 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
Number of polyethylene wear particles
时间窗: Time of revision surgery
counts / g (tissue sample)
Equivalent circle diameter of polyethylene wear particles
时间窗: Time of revision surgery
Equivalent circle diameter (㎛)
Aspect ratio of polyethylene wear particles
时间窗: Time of revision surgery
Aspect ratio
Roundness of polyethylene wear particles
时间窗: Time of revision surgery
Roundness
次要结局
- Body mass index(Time of revision surgery)
- Knee injury and Osteoarthritis Outcome Score for Joint Replacement(Time of revision surgery)
- University of California at Los Angeles activity score(Time of revision surgery)
- Knee joint flexion angle(Time of revision surgery)
- 2011 Knee Society Score: A Patient Expectation Score(Time of revision surgery)
- Knee joint extension angle(Time of revision surgery)
- 2011 Knee Society Score: An "Objective" Knee Score(Time of revision surgery)
- 2011 Knee Society Score: A Patient Satisfaction Score(Time of revision surgery)
- 2011 Knee Society Score: A Functional Activity Score(Time of revision surgery)
研究者
Yukihide Minoda
Associate professor
Osaka Metropolitan University