Community Based Rehabilitation After Knee Arthroplasty

Knee Arthroplasty Clinical Trial

— CORKA  

Official title:

COmmunity Based Rehabilitation After Knee Arthroplasty (CORKA): A Prospective Two Arm Individually Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867772
• Other study ID #: 3.0 25Nov2015
• Status: Completed
• Phase: N/A
• Start date: March 17, 2015
• Est. completion date: March 30, 2018

Study information

• Verified date: April 2021
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 621
• Est. completion date: March 30, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Other:
• Home based rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	HTA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the safety and serious adverse events associated with the treatment programme: SAE	Safe and effective SAE reports	over 12 months
Secondary	To assess the acceptability to the treatment programme for patients and therapists through both a RCT and a nested qualitative study	Qualatative interviews	over 12 months
Secondary	To assess the cost effectiveness of the different treatment strategies	QALY	over 12 months