Patellar Resurfacing in Total Knee Arthroplasty. A Prospective, Randomised and Double Blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Knee injury and Osteoarthritis Outcome Score
研究概览
简要总结
Background:
The best treatment of the patella during total knee arthroplasty (TKA) is controversial. The implantation of a patellar component adds to the operation time and the costs of the operation.There is a huge variation as to whether the patella is resurfaced or not during TKA. Meta-analysis of prospective, randomised trials might indicate that patellar resurfacing reduces the risk of reoperation and anterior knee pain, but drawing firm conclusions is not possible and additional, high quality randomised trials are required.
Purpose:
The aim of this study is to determine whether ther is a difference between the two groups in knee pain, functions, patient satisfaction and quality of life after TKA.
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, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients less than 85 years old with osteoarthritis scheduled for primary knee arthroplasty.
排除标准
- •Patients who are not able to cooperate
- •Serious deformity (not suitable for a standard CR 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 injury and Osteoarthritis Outcome Score
时间窗: 3 years follow up
次要结局
- Oxford score, Knee Society score, Stair climbing test, Pain (VAS), Patient satisfaction (VAS)(3 years follow up)
研究者
Eirik Aunan
MD
Sykehuset Innlandet HF