Comparison of Clinical Results of Patella Resurfacing Versus Patellar Retention Under Subvastus Approach in Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Knee Society score
研究概览
简要总结
This study aims to compare the clinical results of patella resurfacing or not under subvastus approach in total knee arthroplasty. Even though the excellent results of total knee arthroplasty(TKA), there is persistent controversy over whether or not to replace the patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some surgeons always performed patella resurfacing during total knee arthroplasty but the others didn't do that. It's up to surgeon's preference. There were several studies of patellar resurfacing or not in TKA. But previous studies almost have been done under other approach, not a subvastus approach.
This study prospectively randomized patients receiving bilateral TKA with patellar resurfacing or not in each knee. Patients preference and clinical results was investigated in both knee of same patients who received patellar resurfacing or not during minimum 2 year follow up.
详细描述
The primary objective of this work was to compare pain, stiffness and function between groups at minimum 2 year postoperatively. Secondarily, we compared pain, patient preference at minimum 2 year postoperatively. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes.
Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive patella replacement or not in both knee of same patients. Subjects were assessed pre-operatively and at 6 months, 1, 2 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and McMaster Osteoarthritis Index [WOMAC]) . Other measurements like Knee Society score, Feller's score, Patient satisfaction (VAS) also checked pre-operatively and at 6 months, 1, 2 years postoperatively.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients for total knee arthroplasty
- •Having medicare insurance
排除标准
- •Patients who are not able to cooperate
- •Serious deformity (not suitable for a standard TKA prosthesis)
- •Patellar thickness less than 18 mm
- •Prior operation involving the extensor mechanism
- •Rheumatoid arthritis
- •Severe medical disability limiting the ability to walk
- •Revision surgery
- •Knees with predominantly patellofemoral arthrosis
结局指标
主要结局
Knee Society score
时间窗: Change from preoperative score to postoperative 2 years
WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale
时间窗: Change from preoperative score to postoperative 2 years
次要结局
- Feller's score(Change from preoperative score to postoperative 2 years)
- Patients satisfaction using Visual Analog Score for pain(Change from preoperative score to postoperative 2 years)
研究者
Yong In
Professor
The Catholic University of Korea