Partial Synovectomy in Articular Side of Quadriceps Tendon Reduces Crepitus After Posterior Stabilized Total Knee Arthroplasty : a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Crepitus grade
研究概览
简要总结
Crepitus causing unsatisfied result to patients after posterior stabilized total knee arthroplasty. Recent retrospective study demonstrated removal of hyperplastic synovium in distal quadriceps caused reduce of crepitus. However, this study has limitation of time gap exist between arms, different in observation time and bias caused by retrospective review. Thus aim of this study is that by randomized trial, verified hyperplastic synovium in distal quadriceps causing crepitus.
Target enrolled patients in this study are scheduled to perform both total knee arthroplasty. Experimental group is randomized side (right or left) of knee, and control group is other side of knee. Both arms decided by randomized number table. Crepitus measured after 3mo, 6mo, 1year after surgical treatment
详细描述
Surgical treatment of TKA with synovium removal in distal quadriceps tendon performed classifed as experimental arm and TKA wiout synovium removal classified as control arm. Before surgical treatment, radiologic and physiological evaluation performed to check too much variance shown in either arm. Radiologic parameter include Hip knee ankle angle, Femoral tibial angle, Level of joint line, Insall-Salvati ratio, Posterior tibial slope, Posterior femoral condylar offset, Patellar thickness, Patellar tilt, Patellar displacement. During surgical treatment patella resurfacing in either group excluded this study. Indication of patella resufacing is ICRS grade IV in lateral surface of patella. After surgical procedure done check grade of crepitus (0-no crepitation, 1-fine crepitation, 2-coarse crepitation) with WOMAC, Knee Society Score, Eq-5D (European quality of life -5 Dimensions), Forgotten joint score after 3month, 6month and 1year after surgical procedure.
Other collecting variance Age, Gender, BMI, Range of motion of knee, Fmoeral/Tibial component size, PE thickness
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients who scheduled to perform both total knee arthroplasty(TKA) using posteiror crucitate sustain type (PS)
排除标准
- •Lost follow up (Including death of patient)
- •Unexpected complication (e.g) Infection, periprosthetic fracture)
- •Patella resurfacing
- •Canceled surgical treatment
- •Refused to enrolled study
- •Too much radiological or physicological variance shown between either knee
结局指标
主要结局
Crepitus grade
时间窗: 3month, 6month, 1year after surgical treatment
Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus
次要结局
- Hip knee ankle angle(3month, 6month, 1year after surgical treatment)
- Insall-Salvati ratio(3month, 6month, 1year after surgical treatment)
- Patellar displacement(3month, 6month, 1year after surgical treatment)
- Patellar tilt angle(3month, 6month, 1year after surgical treatment)
- Tibia offset(3month, 6month, 1year after surgical treatment)
- Knee society score(3month, 6month, 1year after surgical treatment)
- WOMAC score(3month, 6month, 1year after surgical treatment)
- Forgotten joint score(3month, 6month, 1year after surgical treatment)
研究者
Woo Suk Lee
professor
Gangnam Severance Hospital