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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05124613
Other study ID # NHS001829
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 27, 2021
Est. completion date May 2022

Study information

Verified date November 2021
Source University of Manchester
Contact Gwenllian Tawy, PhD
Phone 01617462371
Email gwenllian.tawy@manchester.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 2022
Est. primary completion date May 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

Other:
Survey
Information collected and stored in Survey: Type of knee surgery the patient is waitlisted for Demographics: age, sex, recent weight gain Validated and bespoke questions: EQ-5D survey (a validated questionnaire on health) Bespoke questions on knee pain today Bespoke questions on knee function today Bespoke questions on change in knee pain since being waitlisted for surgery Bespoke questions on change in knee function since being waitlisted for surgery Bespoke questions on coping mechanisms patients use to manage symptoms Bespoke questions on what support they would find beneficial whilst they wait for their surgery Three bespoke questions about COVID-19 (Have they ever tested positive/Has the pandemic changed their mind about wanting surgery/Has the perception of their knee pain and function changed since the first lockdown was introduced?)

Locations

Country Name City State
United Kingdom Trafford General Hospital Manchester

Sponsors (2)

Lead Sponsor Collaborator
University of Manchester Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in perceived knee pain 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 Up to 2 years
Primary Change in perceived knee function 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 Up to 2 years
Secondary Change in symptom management The survey will ask patients to describe how they are managing their symptoms during the COVID-19 pandemic and describe whether this has changed since the pandemic started. Up to 2 years
Secondary Support The survey will ask patients to describe what kinds of support they would like to receive whilst they wait for their delayed surgery to take place (current). Up to 1 year
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