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临床试验/NCT05124613
NCT05124613Unknown不适用

The Impact of Covid-19 on Patients Waiting for Elective Knee Surgery: An Investigation Into Patient Perceptions of Knee Function and Pain

University of Manchester1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年5月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Change in perceived knee pain

研究概览

简要总结

The Covid-19 pandemic has led to the postponement and cancellation of elective orthopaedic surgeries worldwide. These delays to elective procedures combined with ongoing demand have led to increasingly longer waiting list times.

This cross-sectional pilot study aims to investigate the change in patients' perceptions of knee pain and function since being waitlisted for surgery. A bespoke survey will be administered to eligible patients over the phone from Trafford General Hospital, Manchester. The survey will also investigate the coping mechanisms and the preventative measures patients are taking to manage symptoms during the pandemic, and question what kinds of communication and support patient would like to be offered whilst waiting for treatment.

This study will improve clinicians' and researchers' understanding of how patients are coping with symptoms during this pandemic, and provide information on how to better support patients who are waiting for knee surgery. This information could be used to enhance orthopaedic care during, and in the aftermath, of this pandemic. The information gathered in this study may also be used to inform a larger multi-centre study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients identified by a consultant orthopaedic surgeon as being on a waiting list for surgery on their knee.
  • Patients identified by a consultant orthopaedic surgeon who are experiencing a delay to their knee surgery as a result of the COVID-19 pandemic.
  • Patients over 18 years old.

排除标准

  • Patients who are no longer waiting for their surgery (e.g. surgery performed elsewhere or patient has changed their mind about undergoing surgery).
  • Patients who are on a waiting list for any surgery other than surgery of the knee.
  • Patients who are on a waiting list for surgery at a hospital which is not a part of Manchester University NHS Foundation Trust.
  • Patients who cannot read and speak English.
  • Patients who cannot complete the survey over the phone.
  • Patients who cannot give informed consent due to cognitive impairment (e.g. dementia or similar cognitive condition).

结局指标

主要结局

Change in perceived knee pain

时间窗: Up to 2 years

The survey will ask patients to compare the level of pain they have in their knee now to the level of pain they had in their knee when they were put on the waiting list for knee surgery

Change in perceived knee function

时间窗: Up to 2 years

The survey will ask patients to compare the level of function they have in their knee now to the level of function they had in their knee when they were put on the waiting list for knee surgery

次要结局

  • Support(Up to 1 year)
  • Change in symptom management(Up to 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leela Biant

Professor

University of Manchester

研究点 (1)

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