Osteoarthritis, KneeNCT05124613
The Impact of Covid-19 on Patients Waiting for Knee Surgery
An observational study of Osteoarthritis, Knee and Osteochondral Defect, run by University of Manchester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteochondral Defect, Cartilage Injury
- What is being tested?
- Survey
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 May 2021to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults awaiting surgery on the knee who have experienced delays to their procedure due to the COVID-19 pandemic.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Trafford General Hospital
Manchester, M415SL
Leela Biant
Leela Biant
About this study
Official title: 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.
- Conditions
- Osteoarthritis, Knee, Osteochondral Defect, Cartilage Injury, Cartilage Damage, Knee Injuries, Knee Injuries and Disorders
- Being tested
- Survey
- Keywords
- COVID-19, Knee Surgery, Knee Pain, Knee Function, Coping Mechanisms
- Medical subject headings
- Osteoarthritis, Knee, Knee Injuries, Disease, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- 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?)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 2 years
Secondary outcomes (2)
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.
Measured: 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).
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start27 May 2021
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Leela Biant, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124613
- Sponsor's protocol ID
- NHS001829
- Status last verified
- Nov 2021
- First submitted
- 6 Mar 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Covid-19 on Patients Waiting for Elective Knee Surgery: An Investigation Into Patient Perceptions of Knee Function and Pain
- ClinicalTrials.gov ID
- NCT05124613
- Acronym / sponsor ID
- NHS001829
- Conditions
- Osteoarthritis, Knee, Osteochondral Defect, Cartilage Injury, Cartilage Damage, Knee Injuries, Knee Injuries and Disorders
- Keywords
- COVID-19, Knee Surgery, Knee Pain, Knee Function, Coping Mechanisms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- 27 May 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients waitlisted for Knee Surgery | – | Other: SurveyAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults awaiting surgery on the knee who have experienced delays to their procedure due to the COVID-19 pandemic.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyInformation 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?) | Other | Patients waitlisted for Knee Surgery |
Primary outcome
Change in perceived knee pain
Time frame: Up to 2 years
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
Change in perceived knee function
Time frame: Up to 2 years
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
2 secondary outcomes
Change in symptom management
Time frame: Up to 2 years
Support
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No. No individual participant data will be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Osteochondral Defect, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gwenllian Tawy, PhD (01617462371, gwenllian.tawy@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived knee pain (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.