Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cumulative bone cement penetration
研究概览
简要总结
Background
Bone irrigation is essential in cemented total knee arthroplasty surgical technique in order to improve cement penetration and interdigitation into cancellous bone, that is going to determine the strength of the bone-cement interface.
Purpose
To report the effect of high-pressure pulsatile lavage versus manual rinsing on bone cement penetration in total knee arthroplasty.
Methods
This is a single-centre, prospective, randomized, controlled clinical trial. The study included 100 patients undergoing primary total knee arthroplasty. All patients meeting inclusion criteria were randomly assigned to the pulsed lavage or non-pulsed lavage group. The cumulative bone cement penetration was radiologically assessed in antero posterior and lateral radiograph views in 10 zones according to the Knee Society Scoring System. A statistical analysis was performed between both groups comparing bone cement penetration cumulative scores.
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, Investigator)
入排标准
- 年龄范围
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >60 years
- •Age <89 years
- •Clinical symptoms of knee osteoarthritis
- •Failed conservative treatment
排除标准
- •Metal allergies
- •Active or latent knee sepsis
- •Extensor mechanism dysfunction
- •Morbid obesity
- •Several peripheral vascular disease
- •Noncompliance due to major psychiatric or neurological disorders.
结局指标
主要结局
Cumulative bone cement penetration
时间窗: 48 hours postoperative xrays
The cumulative bone cement penetration was radiologically assessed in AP and lateral radiograph views in 10 zones according to the Knee Society Scoring System (for each zone, \<4 = nonprogressive, 5-9 = risk of progression, \>10 = risk of failure) - minimum 0, maximum non established-.
次要结局
未报告次要终点