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Clinical Trials/NCT05124613
NCT05124613
Unknown
Not Applicable

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 site in 1 country300 target enrollmentMay 27, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
University of Manchester
Enrollment
300
Locations
1
Primary Endpoint
Change in perceived knee pain
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 27, 2021
End Date
May 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leela Biant

Professor

University of Manchester

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

Change in perceived knee pain

Time Frame: 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

Time Frame: 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

Secondary Outcomes

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

Study Sites (1)

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