ISRCTN27624068进行中(未招募)3 期
Robotic Arthroplasty: a Clinical and cost Effectiveness Randomised controlled trial (RACER)
niversity Hospitals Coventry and Warwickshire NHS Trust0 个研究点目标入组 339 人开始时间: 2020年7月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 339
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37295832/ (added 12/06/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Osteoarthritis of the knee with pain, disability and changes on standard of care clinical images (x-rays or MRI according to normal clinical practice) that, in the opinion of the treating clinician, warrants total knee replacement (TKR)
- •2. Conservative therapy has been unsuccessful, as judged by the treating clinician
排除标准
- •1. Osteoarthritis secondary to inflammatory arthropathy or intra-articular fracture as determined by the treating clinician
- •2. Revision surgery or need for complex implants, or any other implant than a standard Triathlon total knee replacement (TKR), as determined by the treating clinician. This includes nickel-free implants as well as those that require a long stem, augments, or custom made devices
- •3. Age <18 years
- •4. Unfit for TKR, or surgery is otherwise contraindicated (for example, concurrent infection)
- •5. Previous randomisation in the present trial (i.e. other knee)
- •6. Unable to take part in trial processes, including prisoners or people unable to communicate or complete questionnaires in English, or people unable to give informed consent
研究者
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