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Community Based Rehabilitation After Knee Arthroplasty

NCT ID: NCT04867772

Last Updated: 2021-04-30

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

621 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-17

Study Completion Date

2018-03-30

Brief Summary

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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

Detailed Description

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Conditions

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Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 arm RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type OTHER

Home based rehabilitation

Intervention Type OTHER

Intervention

Participants will receive a home based rehabilitation programme with 1-7 sessions of physiotherapy delivered over 12 weeks.

Group Type EXPERIMENTAL

Home based rehabilitation

Intervention Type OTHER

Interventions

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Home based rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HTA

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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3.0 25Nov2015

Identifier Type: -

Identifier Source: org_study_id