MedDataX Logo

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

NCT ID: NCT05124613

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-27

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee Osteochondral Defect Cartilage Injury Cartilage Damage Knee Injuries Knee Injuries and Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

COVID-19 Knee Surgery Knee Pain Knee Function Coping Mechanisms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Survey

Intervention Type OTHER

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:

1. EQ-5D survey (a validated questionnaire on health)
2. Bespoke questions on knee pain today
3. Bespoke questions on knee function today
4. Bespoke questions on change in knee pain since being waitlisted for surgery
5. Bespoke questions on change in knee function since being waitlisted for surgery
6. Bespoke questions on coping mechanisms patients use to manage symptoms
7. Bespoke questions on what support they would find beneficial whilst they wait for their surgery
8. 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?)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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:

1. EQ-5D survey (a validated questionnaire on health)
2. Bespoke questions on knee pain today
3. Bespoke questions on knee function today
4. Bespoke questions on change in knee pain since being waitlisted for surgery
5. Bespoke questions on change in knee function since being waitlisted for surgery
6. Bespoke questions on coping mechanisms patients use to manage symptoms
7. Bespoke questions on what support they would find beneficial whilst they wait for their surgery
8. 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?)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Leela Biant

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Trafford General Hospital

Manchester, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gwenllian Tawy, PhD

Role: CONTACT

Phone: 01617462371

Email: [email protected]

Leela Biant, MB ChB

Role: CONTACT

Phone: 01617462391

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Leela Biant

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NHS001829

Identifier Type: -

Identifier Source: org_study_id