Randomized Control Trial of Staged Versus Simultaneous Bilateral Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 224
- 试验地点
- 8
- 主要终点
- Veterans Rand 12-item Health Survey Score (VR-12)
研究概览
简要总结
The purpose of this study is to assist surgeons and patients in answering the question "Should I have both knees replaced at the same time, or should I just do one and wait to do the second one?"
详细描述
This is a multi-center randomized controlled trial of 224 patients in order to clearly delineate differences in post-operative outcomes and the trajectory of recovery between simultaneous and staged bilateral KA. The primary outcome measure is difference in generic health related quality of life between the two groups measured 1 year following surgery. Secondary outcome measures include differences in joint specific scores, time off work, satisfaction and costs.
This trial will inform patients and clinicians about differences in recovery, function and efficacy of the procedure to aid in the selection of treatment pathway to best suit the patient.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients considering bilateral knee arthroplasty
- •Patients must sign the consent form
- •Patients must be willing to complete the study questionnaires for the duration of the study
排除标准
- •Patients who require simultaneous bilateral knee replacement surgery in order to manage significant bilateral flexion or valgus knee contractures where staged procedures may result in suboptimal outcomes by increasing the risk of post-operative flexion contracture in the "first replaced" knee
- •patients who are unable to complete the questionnaires
研究组 & 干预措施
Total Knee Arthroplasty (TKA)
Patient will have complete replacement - Simultaneous vs Staged
干预措施: Simultaneous Knee Arthroplasty (UKA) (Procedure)
Total Knee Arthroplasty (TKA)
Patient will have complete replacement - Simultaneous vs Staged
干预措施: Staged Knee Arthroplasty (UKA) (Procedure)
Unicompartmental Knee Arthroplasty (UKA)
Patient will have half-knee replacement (partial) - Simultaneous vs Staged
干预措施: Simultaneous Knee Arthroplasty (UKA) (Procedure)
Unicompartmental Knee Arthroplasty (UKA)
Patient will have half-knee replacement (partial) - Simultaneous vs Staged
干预措施: Staged Knee Arthroplasty (UKA) (Procedure)
结局指标
主要结局
Veterans Rand 12-item Health Survey Score (VR-12)
时间窗: 1 Year
The VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health; patient-reported.
次要结局
- Hospital stay(Up to 1 week)
- Complications(Intraoperative, 6 months, 12 months, 18 months, 24 months)
- Joint function (Oxford-12 knee score)(Pre-operative, 6 months, 12 months, 18 months, 24 months)
- Transfusion rate(Up to 1 week)
- Costs of knee replacement surgery(Up to 1 week)
- Return to work(Pre-operative, 6 months, 12 months, 18 months, 24 months)
- Patient satisfaction(6 months, 12 months, 18 months, 24 months)