Systematic Lateral Retinacular Release Does Not Reduce Post-Operative Anterior Knee Pain After Primary Total Knee Arthroplasty With Patellar Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Change from baseline in Anterior Knee Pain at one year after surgery
研究概览
简要总结
The aim of this study is to assess the effect of systematic lateral retinacular release on anterior knee pain, as well as its impact on the functional and radiological outcomes after total knee arthroplasty with patellar resurfacing.
详细描述
Anterior knee pain is an important cause of persistent pain after total knee arthroplasty. Lateral retinacular release has been proposed as a procedure to prevent anterior knee pain syndrome, based on the reduction of lateral tension and improving patellar tracking.
However, its effect on anterior knee pain after total knee arthroplasty is not clear when it is not strictly needed to correct maltracking.
The purpose of this trial is to evaluate the effect of systematic lateral retinaculare release on anterior knee pain, peformed during a total knee arthroplasty with patellar resurfacing.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of knee osteoarthritis
排除标准
- •prior major surgery on the same knee (high tibial or distal femoral osteotomy, patellar realignment)
- •important preoperative malalignment (varus or valgus >15º or flexion deformity >15º)
- •inability to sign informed consent
研究组 & 干预措施
Lateral retinacular release group
During the implantation of a total knee arthroplasty a lateral retinacular release is performed
干预措施: Lateral retinacular release (Procedure)
Non-release group
No aditional gesture in the lateral retinaculum is performed during the implantation of a total knee arthroplasty
结局指标
主要结局
Change from baseline in Anterior Knee Pain at one year after surgery
时间窗: At the preoperative visit and at the 1-year follow up
Pressure pain threshold determined using pressure algometry
Change from baseline in Knee Pain measured by Visual Analogue Scale at one year after surgery
时间窗: At the preoperative visit and at the 1-year follow up
The Visual Analogue Scale referred by the patients at rest, when walking and when going up and downstairs. Scored between 0 (no pain at all) and 10 (maximum pain the patient could imagine).
次要结局
- Change from baseline in patellar pain and function at one year after surgery(At the preoperative visit and at the 1-year follow up)
- Change from baseline in knee fuction, measured by the Knee Society Score, at one year after surgery(At the preoperative visit and at the 1-year follow up)
研究者
Carlos Torrens
Clinical Professor
Hospital del Mar