Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- evaluation of the forgotten joint score (FJS12)
研究概览
简要总结
The aim of this study is to compare the forgotten joint score for the medial pivot polyethylene and ultra-congruent polyethylene which are used in total prosthetic replacement of the knee
详细描述
Total knee arthroplasty is usually effective at improving the quality of life of patients suffering from arthritis.
Over the years, patient expectations about the quality of life post-implantation continue to rise.
It is therefore essential to improve continuously surgical techniques and implants to fulfill patient expectations in terms of pain and movements.
The prosthetic device is composed of a metallic femoral unit, which imitates the articular surface of the femur, and a metallic tibial baseplate covered with a polyethylene (a highly resistant polymer) insert which articulates between the femur and the tibia. This insert can take several forms such as medial pivot or ultra-congruent.
This polymer provides an interface between the two metallic units forming the prothetic device. It has two roles: it provides a lasting contact surface and it offers stability to the knee in substitution of the ligaments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Arm 1: Total knee replacement with medial pivot polyethylene
Arm 2: Total knee replacement with ultra-congruent polyethylene
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 to 90 years of age, eligible for a primary total knee replacement for gonarthrosis
- •Competent subjects able to give informed consent to participate in the research
- •Affiliation to the social security system
排除标准
- •Infection history of the knee to be replaced
- •Deformity greater than 15 degrees
- •Any surgical and/or anesthetic contraindication, or any condition deemed by the investigator to be incompatible with the research.
- •Any contraindication mentioned in the instructions for use of the medical device
- •Pregnant or breastfeeding women
- •Recent infection history of the surgical site
- •Adults who are subject to a legal protection measure or who are unable to express their constent (Article L1121-8 of the French Public Health Code) and subjects under judicial protection (article L. 1122-2 FPHC)
- •Subjects who refuse to participate
结局指标
主要结局
evaluation of the forgotten joint score (FJS12)
时间窗: Month 12
Forgotten knee score at 6 weeks (FJS-12, evaluated out of 100), which allows the analysis of quality of life specifically in relation to knee pathologies
次要结局
- radiographic alignment(month 12)
- knee joint mobility(month 12)
- pain assessment(month 12)
- the Knee Society Score (KSS)(month 12)
- Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).(Month 12)
- radiological complications(Month 12)