跳至主要内容
临床试验/ISRCTN27624068
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

发起方
niversity Hospitals Coventry and Warwickshire NHS Trust

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