ACTRN12618000817246已完成未知
Does Soft Tissue Balancing Using Intra-Operative Pressure Sensors Improve Clinical Outcomes in Total Knee Arthroplasty? A Multi-Centre Randomised Controlled Trial
Dr Samuel Macdessi0 个研究点目标入组 250 人开始时间: 2018年5月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 20 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. All patients suitable for TKA aged 20-85 years
- •2. Patients who meet the indications for a primary unilateral or bilateral total knee arthroplasty using the Smith & Nephew Legion or Genesis II cruciate-retaining or posterior-stabilised total knee arthroplasty system
- •3. Subjects diagnosed with one or more of the following conditions: osteoarthritis; rheumatoid or other inflammatory arthritis; post-traumatic osteoarthritis
排除标准
- •1. Any surgery where increased prosthetic constraint will be required due to significant ligament deficiencies (such as constrained condylar or rotating hinge prostheses)
- •2. Any surgery performed for acute fracture or tumour involvement
- •3. Participants unable to provide consent or complete questionnaires due to cognitive incapacity or English language deficit
- •4. Participants unable to commit to full follow-up schedule over two years (due to geographic distance or physical challenges)
- •5. Pregnant female, or planning on becoming pregnant during study period
研究者
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