Knee ArthroplastyCORKANCT04867772
Community Based Rehabilitation After Knee Arthroplasty
A study testing Home based rehabilitation in people with Knee Arthroplasty, run by University of Oxford.
Trial summary
Background The CORKA study was developed in response to a commissioned call by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme for research into a functional home based rehabilitation programme for patients who may be at risk of poor outcome after knee arthroplasty. Read more about this study
- Who is it for?
- Ages 55 to 100 years
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Home based rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 621 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2015to 30 Mar 2018
- Phase
- Interventional
- 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 55 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study Male or Female, aged 55 years or above Primary unilateral KR as a scheduled procedure Deemed by study screening tool developed to be at risk of poor outcome Happy to allow physiotherapy teams to attend their home to deliver the Community based rehabilitation programme if randomised to the intervention arm.
Who cannot join
- Any absolute contraindications to exercise Severe cardiovascular or pulmonary disease (New York Heart Association III-IV) Severe dementia, assessed using the hospital dementia screening tool Rheumatoid arthritis Further lower limb arthroplasty surgery planned within 12 months. Serious perioperative complications
About this study
Official title: COmmunity Based Rehabilitation After Knee Arthroplasty (CORKA): A Prospective Two Arm Individually Randomised Controlled Trial
Background The CORKA study was developed in response to a commissioned call by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme for research into a functional home based rehabilitation programme for patients who may be at risk of poor outcome after knee arthroplasty.
Design The CORKA trial is a prospective individually randomised controlled trial with blinded outcome assessment at baseline, 6 and 12 months. The study will also include a qualitative and a health economic analysis. Participants will be randomised to one of two arms, 'home-based rehabilitation' or 'Usual Care'. Those in the usual care arm will receive a minimum of 1 and a maximum of 6 sessions of physiotherapy as delivered locally, e.g. class, one to one, etc. Those in the intervention arm will receive 7 sessions of a functional rehabilitation programme over a 12 week timescale. The intervention will be delivered using physiotherapists and physiotherapy assistants in the participants' home. Participants will be followed up at 6 months and 12 months
- Conditions
- Knee Arthroplasty
- Being tested
- Home based rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based rehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | Participants will receive the care that would usually be received in the local hospital setting. this has been determined as between 1 and 6 sessions of physiotherapy Receives: Other: Home based rehabilitation |
| Intervention | Experimental | Participants will receive a home based rehabilitation programme with 1-7 sessions of physiotherapy delivered over 12 weeks. Receives: Other: Home based rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the patient reported functional outcome and quality of life of the CORKA trial rehabilitation protocol versus standard care in participants at risk of poor outcome after knee replacement
functional outcome LLFDI
Measured: over 12 months
Secondary outcomes (3)
To assess the safety and serious adverse events associated with the treatment programme: SAE
Safe and effective SAE reports
Measured: over 12 months
To assess the acceptability to the treatment programme for patients and therapists through both a RCT and a nested qualitative study
Qualatative interviews
Measured: over 12 months
To assess the cost effectiveness of the different treatment strategies
QALY
Measured: over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start17 Mar 2015
- Primary completion26 Jan 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arm RCT
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- HTA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867772
- Sponsor's protocol ID
- 3.0 25Nov2015
- Acronym
- CORKA
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmmunity Based Rehabilitation After Knee Arthroplasty (CORKA): A Prospective Two Arm Individually Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04867772
- Acronym / sponsor ID
- CORKA / 3.0 25Nov2015
- Conditions
- Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- HTA
- Study start
- 17 Mar 2015 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 30 Apr 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.
Background The CORKA study was developed in response to a commissioned call by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme for research into a functional home based rehabilitation programme for patients who may be at risk of poor outcome after knee arthroplasty.
Design The CORKA trial is a prospective individually randomised controlled trial with blinded outcome assessment at baseline, 6 and 12 months. The study will also include a qualitative and a health economic analysis. Participants will be randomised to one of two arms, 'home-based rehabilitation' or 'Usual Care'. Those in the usual care arm will receive a minimum of 1 and a maximum of 6 sessions of physiotherapy as delivered locally, e.g. class, one to one, etc. Those in the intervention arm will receive 7 sessions of a functional rehabilitation programme over a 12 week timescale. The intervention will be delivered using physiotherapists and physiotherapy assistants in the participants' home. Participants will be followed up at 6 months and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arm RCT
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Other: Home based rehabilitationParticipants will receive the care that would usually be received in the local hospital setting. this has been determined as between 1 and 6 sessions of physiotherapy |
| Intervention | Experimental | Other: Home based rehabilitationParticipants will receive a home based rehabilitation programme with 1-7 sessions of physiotherapy delivered over 12 weeks. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participant is willing and able to give informed consent for participation in the study Male or Female, aged 55 years or above Primary unilateral KR as a scheduled procedure Deemed by study screening tool developed to be at risk of poor outcome Happy to allow physiotherapy teams to attend their home to deliver the Community based rehabilitation programme if randomised to the intervention arm.
Key exclusion criteria (1 listed)
- Any absolute contraindications to exercise Severe cardiovascular or pulmonary disease (New York Heart Association III-IV) Severe dementia, assessed using the hospital dementia screening tool Rheumatoid arthritis Further lower limb arthroplasty surgery planned within 12 months. Serious perioperative complications
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 |
|---|---|---|
| Home based rehabilitation | Other | Intervention, Usual Care |
Primary outcome
To compare the patient reported functional outcome and quality of life of the CORKA trial rehabilitation protocol versus standard care in participants at risk of poor outcome after knee replacement
Time frame: over 12 months
functional outcome LLFDI
3 secondary outcomes
To assess the safety and serious adverse events associated with the treatment programme: SAE
Time frame: over 12 months
To assess the acceptability to the treatment programme for patients and therapists through both a RCT and a nested qualitative study
Time frame: over 12 months
To assess the cost effectiveness of the different treatment strategies
Time frame: over 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Home based rehabilitation in people with Knee Arthroplasty, run by University of Oxford.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the patient reported functional outcome and quality of life of the CORKA trial rehabilitation protocol versus standard care in participants at risk of poor outcome after knee replacement (time frame: over 12 months). 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 30 Apr 2021.