MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence A Feasibility Study for a Randomised Controlled Trial of One-stage or Two-stage Surgery for Prosthetic Knee Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Ease of recruitment of participants
研究概览
简要总结
Following a prosthetic knee joint infection, two types of operative approach can be undertaken to treat the infection: a one-stage or two-stage revision operation. Both approaches are widely used and are good at treating infection but we don't know which has the best long-term outcomes for patients. This trial aims to assess the feasibility of conducting a randomised controlled trial to evaluate whether treating a prosthetic knee infection with one-stage revision surgery gives a better outcome than two-stage revision surgery in terms of patient function and pain, and cost-effectiveness.
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
盲法说明
Blinding of participants and trial personnel will not be possible due to the nature of the intervention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with prosthetic knee infection suitable for either one-stage or two-stage revision surgery
- •Intra-operatively, all cases must have adequate soft-tissue coverage post debridement to allow single or two stage revision surgery.
- •Case meets the International Consensus Meeting criteria for infection
- •Patients having had a Debridement, Anti-biotic and Implant Retained procedure previously or washout/biopsy only of an infected TKR are suitable
排除标准
- •Unable or unwilling to undergo either treatment
- •Lacking capacity to consent to research
- •Refusal to consent to study for any reason
- •Re-revision of prosthetic knee infection if first revision was for infection
- •Presence of tuberculosis infection
结局指标
主要结局
Ease of recruitment of participants
时间窗: 20 months
Number of recruits compared to the number of potential participants.
次要结局
- Comparison of two sites(20 months)
- Explaining the study(20 months)
- Surgeon experience(20 months)
- Protocol adherence(20 months)
- Reasons for non-participation(20 months)
- Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates(20 months)
- Oxford Knee Score (OKS) outcome and completion rates(20 months)
- EQ-5D-5L outcome and completion rates(20 months)
- Patient experience(2 weeks after surgery)
- Healthcare resource utilisation(20 months)