Community Based Rehabilitation After Knee Arthroplasty (CORKA)

April 29, 2021 updated by: University of Oxford

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

621

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual Care
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
Other: Home based rehabilitation
Experimental: Intervention
Participants will receive a home based rehabilitation programme with 1-7 sessions of physiotherapy delivered over 12 weeks.
Other: Home based rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
over 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the safety and serious adverse events associated with the treatment programme: SAE
Time Frame: over 12 months
Safe and effective SAE reports
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
Qualatative interviews
over 12 months
To assess the cost effectiveness of the different treatment strategies
Time Frame: over 12 months
QALY
over 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

HTA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2015

Primary Completion (Actual)

January 26, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 3.0 25Nov2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Arthroplasty

Clinical Trials on Home based rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe