Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty Prospective, Monocentric, Randomized, Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- measure of International Knee Society score (IKS score)
研究概览
简要总结
Total knee arthroplasty is a frequent surgery in France. It currently represents 70,000 interventions per year. The total knee prosthesis is also called tri-compartmental because it allows articulation between the femur and the tibia but also between the femur and the patella.
The patella belongs to the extensor system. It articulates with the femoral trochlea in which it slides. It has an important biomechanical role on the quadriceps strength in addition to allowing flexion-extension movements.
In the case of resurfacing, the joint face of the patella is cut off; A convex polyethylene implant is sealed with cement using studs on the same face.
In case of non-resurfacing, the surgeon leaves in place the cartilage of the patella which will be in direct contact with the femoral prosthetic trochlea.
Both methods have advantages and disadvantages. For some implants, it is recommended to resurface the patella because the implant is not very tolerant with the native patella. Other implants have been designed to be better adapted to the preservation of patellar cartilage.
There is currently no evidence that one method is superior to the other on new generation implants known as "patellar friendly".
It seems necessary to compare both methods in terms of long-term postsurgery results.
详细描述
The analysis of the primary endpoint (International Knee Society score (IKS score)) will be based on the assumption that the postsurgery score will be identical in both groups. The t test for independent samples will be used to test this hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Male or Female (age ≥ 18 years)
- •Diagnosis of knee arthrosis (internal femoro-tibial arthrosis, external femorotibial osteoarthritis, femoro-patellar arthrosis)
- •Indication of total first-line knee arthroplasty
排除标准
- •Patient whose surgical complexity requires the placement of a strained prosthesis (ligament laxity, bone loss).
- •Refusal to participate in the study
- •Pregnant women, parturients or nursing mothers
- •Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research
- •Minor Patients
- •Major persons who are subject to a legal protection measure or are unable to express their consent
- •Patient not affiliated to a social security scheme
- •Patient participating in other interventional research excluding routine care studies not interfering with analysis of primary endpoint
研究组 & 干预措施
Patellar resurfacing
Patellar resurfacing during the total knee prosthesis Anatomic surgery
干预措施: Patellar resurfacing (Other)
Patellar non-resurfacing
Patellar non-resurfacing during the total knee prosthesis Anatomic surgery
干预措施: Patellar non-resurfacing (Other)
结局指标
主要结局
measure of International Knee Society score (IKS score)
时间窗: 12 months after surgery
The comparison of the IKS (International Knee Society) scores (2011 version) will be done between both groups.
次要结局
- Measure of the forgotten joint score(12 months after surgery)
- abnormality of the patellar stroke(12 months after surgery)