Community Based Rehabilitation After Knee Arthroplasty

NCT04867772 | Completed DMC

• 1 other identifier: 3.0 25Nov2015
• Study Type: interventional
• Target: 621
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  over 12 months

Secondary Outcomes (3)

• To assess the safety and serious adverse events associated with the treatment programme: SAE

  over 12 months

• To assess the acceptability to the treatment programme for patients and therapists through both a RCT and a nested qualitative study

  over 12 months

• To assess the cost effectiveness of the different treatment strategies

  over 12 months

Study Arms (2)

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

Other: Home based rehabilitation

Intervention

EXPERIMENTAL

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

Other: Home based rehabilitation

Interventions

Home based rehabilitation OTHER

Intervention; Usual Care

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• HTA: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arm RCT

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: March 17, 2015
• Primary Completion: January 26, 2018
• Study Completion: March 30, 2018
• Last Updated: April 30, 2021

Record last verified: 2021-04