One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty. a Randomized Controlled Multicenter Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 97
- 试验地点
- 9
- 主要终点
- Oxford Knee Score (AUC)
研究概览
简要总结
This study investigates functional outcome and safety after one-stage versus two-stage revision of the infected knee arthroplasty.
Half of participants are treated with a one-stage surgical procedure, while the other half is treated with a two-stage procedure.
The investigators hypothesize that the functional outcome and quality of life of the participants is superior after one-stage surgery compared to two-stage surgery.
详细描述
A two-stage approach is the standard surgical procedure in the treatment of the chronically infected knee arthroplasty, but promising results have been reported after a one-stage approach from single-centre studies.
The potential benefits for the patients treated with a one-stage approach are many as they only have to go through surgery and rehabilitation once with shorter total length of hospital stay. However, no randomized controlled trials comparing outcome after the procedures have been performed so far.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs of periprosthetic knee infection
- •> 6 weeks from previous knee arthoplasty procedure (primary or total revision procedure)
- •Speak and understand Danish and have given informed consent
排除标准
- •Soft tissue problems requiring plastic surgery
- •major bone loss requiring mega/tumor-prosthesis
- •acute surgery due to sepsis
- •malignant disease with less than 2 years life expectancy
- •re-infection with previous two-stage procedure
- •bilateral knee infection
结局指标
主要结局
Oxford Knee Score (AUC)
时间窗: preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively.
Area Under Curve for Oxford Knee Score
次要结局
- Re-revision rate(2 year postoperatively)
- mortality(90 days postoperatively and 1 and 2 year postoperatively)
- Range of Motion(2 years postoperatively)
- Oxford Knee Score (AUC)(preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.)
- EQ-5D-5L(preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.)
- readmission rate(90 days postoperatively)
研究者
Martin Lindberg-Larsen
Orthopaedic Surgeon, MD, PhD
Odense University Hospital