Effect of Using Mobile Bearing on the Incidence Rate of Anterior Knee Pain in Primary Total Knee Arthroplasty Without Patellar Resurfacing (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Anterior knee pain
研究概览
简要总结
Osteoarthritis is the most common cause of chronic joint disease, and its incidence has increased due to the high average life expectancy, in addition to the high incidence of obesity. Total knee arthroplasty is currently an accepted treatment for severe degenerative conditions and there are various implant systems with special features depending on component geometry, degree of fit of the articular surfaces, and fixation techniques. A tibial component with mobile polyethylene has been developed as an alternative to fixed polyethylene because it has theoretical advantages in terms of increasing the range of motion, reducing wear conditions, and reducing the incidence of anterior knee pain when the articular surface of the patella is not resurfaced.
详细描述
The study is a randomized controlled clinical trial where the sample will be collected within one year from the date of approval of the Scientific Research Council at Damascus University. The sample consists of patients undergoing a total primary knee arthroplasty without patellar resurfacing following primary arthritis knee. The patients will be randomly divided into two groups. The first will be a primary total knee arthroplasty with a mobile bearing, and the second group with a fixed bearing. Then the patients will be followed for at least one year.
The data of the patients included in the study will be collected before the surgical operation, then the surgery; followed up for at least one year after it, and then compared between the two groups in terms of a range of motion and functional and clinical results according to the Knee Society Score (KSS) and the anterior knee pain scale, and patient satisfaction assessment according to the Forgotten Joint Scale (FJS).
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with expected primary total knee arthroplasty
排除标准
- •Mediolateral instability
- •Infective arthritis
- •Severe deformity
- •Patients with severe obesity according to the Body Mass Index (BMI < 35).
结局指标
主要结局
Anterior knee pain
时间窗: 1-2 years after surgery
Anterior knee pain will be assessed by questionnaire.
次要结局
- Forgotten Joint Scale (FJS)(1-2 years after surgery)
- Knee Society Score (KSS)(1-2 years after surgery)
- perioperative complications(assessed within two weeks intervals until 6 months after surgery)