A Prospective Randomized Clinical Study of Patellar Resurfacing and Non-resurfacing in One-stage Bilateral Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 主要终点
- Change From Baseline in anteroposterior long weight-bearing X-ray
研究概览
简要总结
The literature regarding resurfacing of the patella in total knee arthroplasty has conflicting conclusions. This study assesses medium-term clinical results of total knee arthroplasties performed with and without the patellar resurfacing in patients undergoing single-staged bilateral total knee arthroplasty in a randomized controlled, clinical study at a minimum of 5 years follow-up.
详细描述
Sixty-six patients (132 knees) underwent primary single-staged bilateral total knee arthroplasty for osteoarthritis. Patients were randomized to receive resurfacing or retention of the patella. All patients received the Scorpio NRG knee prosthesis. Evaluations were done preoperatively and yearly, up to a minimum of 5 years postoperatively. Knee Society Score and Feller Score outcomes were measured. Anterior knee pain, the clunk of patella, and patient satisfaction questionnaires were completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •degenerative OA
- •50-75 years
- •All patients with OA were bilateral knee OA
排除标准
- •previous patellectomy
- •inflammatory arthritis
- •patellar fracture
- •patellar instability
- •previous extensor mechanism procedures
- •high tibial osteotomy,
- •severe valgus or varus deformity (> 20°), severe flexion contracture (> 30°)
- •previous unicondylar knee replacement
- •a history of septic arthritis or osteomyelitis.
结局指标
主要结局
Change From Baseline in anteroposterior long weight-bearing X-ray
时间窗: Baseline,1,2,3,4 and 5 years
anteroposterior long weight-bearing X-ray
Change From Baseline in knee society score ( KSS)
时间窗: Baseline,1,2,3,4 and 5 years
The knee society score ( KSS) which consists of a 100-point scale for knee score and 100-point score for function score. The knee score has points for pain (0 worst -50 best ), range of motion (0 worst -25 best ) and stability (0 worst -25 best ). scores from each item are summed to produce a total score .The function score has points for walking ability (0 worst -50 best ) and stair climbing ability (0 worst -50 best ), scores from each item are summed to produce a total score.The knee score and the function score are recorded respectively.The higher values represent a better outcome.
Change From Baseline in the Feller score
时间窗: Baseline,1,2,3,4 and 5 years
The Feller score consists four parts.Total score is 30 score (0-30) and the higher values represent a better outcome. The Feller score has points for Anterior knee pain (0 worst-15 best), quadriceps strength (1 worst -5 best) , ability to rise from chairand stability(0 worst-5 best )and stair-climbing(2 worst-5 best ). The scores from each item are summed to produce a total score
Change From Baseline in visual analogue scale (VAS)
时间窗: Baseline,1,2,3,4 and 5 years
The Visual analogue scale (VAS)is ranging from 0 to 10 points, with 0 being no pain and 10 being maximum pain.The higher values represent a worse outcome.
Change From Baseline in MOS item short from health survey(SF-36)
时间窗: Baseline,1,2,3,4 and 5 years
The MOS item short from health survey(SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
次要结局
未报告次要终点