Safety of Single-stage, Two-team, Simultaneous Bilateral Total Knee Arthroplasty Compared to One-team: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Number of major complications
研究概览
简要总结
The effects of two-team and single-team simultaneous bilateral total knee arthroplasty (SBA) on peri- and postoperative complications are not clear. The investigators hypothesized that two-team SBA has lower early postoperative complication rates than single-surgeon SBA. Therefore, this prospective study compared minor and major complications for 90 days postoperatively between two-surgeon and single-surgeon SBA.
详细描述
Study Design:
This prospective randomized study was approved by our institution's Clinical Research Ethics Committee (08.11.2017-71306642-050.01.04). The protocol conforms to CONSORT guidelines for parallel-group randomized trials and the protocol is designed to conform to the principles of the Declaration of Helsinki.
Participant :
The investigators will enroll 246 patients with primary bilateral symptomatic knee osteoarthritis that was refractory to conservative treatment who underwent bilateral TKA (total knee arthroplasty) under single anaesthesia between 2017 and 2018. An informed consent form will be obtained from all patients.
The schedule for randomization was randomly generated using a computer before the initiation of the trial. Patients were randomly assigned in a 1:1 ratio. A blind medical staff member will organize the days of the surgeries of randomized patients for the two-surgeon (TS) or single-surgeon (SS) groups. Neither patients nor assessors will know about randomization results. The outcome assessor will be blinded to group allocation and will no involve in providing the interventions. The statistician performing the statistical analyses will be blinded to group allocation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary bilateral knee osteoarthritis with refractory to conservative treatment
- •Patients who accept participation in the research and the randomization
排除标准
- •no history of malignancy
- •less than 75 years old
- •without severe extra-articular deformities
- •severe cardiac insufficiency and morbid obesity
- •without systemic inflammatory diseases
结局指标
主要结局
Number of major complications
时间窗: 90 days
Systemic and local major complications will evaluate. Major complications are conditions that require long-term hospitalization and repetitive intervention.
次要结局
- Number of minor complications(90 days)
- Estimated blood loss(1 day after operation)
- WOMAC knee score(90 days)
- Oxford Knee Score(90 days)
研究者
Gökçer Uzer
Associate Professor
Bezmialem Vakif University