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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Knee Injuries; Cartilage Injury; Cartilage Damage; Knee Injuries and Disorders; Osteochondral Defect
• Intervention / Treatment: Other: Survey

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Gwenllian Tawy, PhD; Phone Number: 01617462371; Email: gwenllian.tawy@manchester.ac.uk
• Study Contact Backup: Name: Leela Biant, MB ChB; Phone Number: 01617462391; Email: leela.biant@manchester.ac.uk

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M415SL
    • Recruiting
    • Trafford General Hospital
    • Contact: Leela Biant
    • Principal Investigator: Leela Biant
    • Sub-Investigator: Gwenllian Tawy
    • Sub-Investigator: Elaine Paul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults awaiting surgery on the knee who have experienced delays to their procedure due to the COVID-19 pandemic.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients waitlisted for Knee Surgery; Adults identified by a consultant orthopaedic surgeon at the study site as being on a waiting list for surgery on their knee and as experiencing a delay to their knee surgery as a result of the COVID-19 pandemic will be eligible to participate in this survey. The survey will include one validated questionnaire and a series of bespoke questions.

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 todayBespoke questions on knee function todayBespoke questions on change in knee pain since being waitlisted for surgeryBespoke questions on change in knee function since being waitlisted for surgeryBespoke questions on coping mechanisms patients use to manage symptomsBespoke questions on what support they would find beneficial whilst they wait for their surgeryThree 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?)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: Manchester University NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: March 6, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Knee Pain; COVID-19; Knee Function; Knee Surgery; Coping Mechanisms
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; COVID-19; Osteoarthritis, Knee; Wounds and Injuries; Knee Injuries
• Other Study ID Numbers: NHS001829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual participant data will be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No