The Impact of Covid-19 on Patients Waiting for Knee Surgery

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05124613
• Other study ID #: NHS001829
• Status: Recruiting
• 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
• 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).

Related Conditions & MeSH terms

• Cartilage Damage
• Cartilage Injury
• COVID-19
• Knee Injuries
• Knee Injuries and Disorders
• Osteoarthritis, Knee
• Osteochondral Defect
• Wounds and Injuries

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