NCT05124613

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

March 6, 2021

Last Update Submit

November 17, 2021

Conditions

Keywords

COVID-19Knee SurgeryKnee PainKnee FunctionCoping Mechanisms

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change in symptom management

    Up to 2 years

  • Support

    Up to 1 year

Study Arms (1)

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

Interventions

SurveyOTHER

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?)

Patients waitlisted for Knee Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trafford General Hospital

Manchester, M415SL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeKnee InjuriesDiseaseCOVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesLeg InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2021

First Posted

November 18, 2021

Study Start

May 27, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

November 18, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

No individual participant data will be available to other researchers.

Locations