The HIHO Study: Hospital Inpatient vs Home Rehabilitation After Total Knee Replacement

Osteoarthritis Clinical Trial

— HIHO  

Official title:

Randomised Controlled Trial Comparing Hospital Inpatient vs Home Rehabilitation After Total Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583153
• Other study ID #: HIHO-1042554
• Status: Completed
• Phase: N/A
• First received: April 19, 2012
• Last updated: April 13, 2016
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: South West Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Total knee replacement (TKR) surgery is a common and highly effective treatment option for alleviating the pain and disability caused by chronic arthritis. The associated rehabilitation costs, however, impose a significant burden on the health system. In particular, inpatient rehabilitation - utilised by approximately 43% of private TKR recipients in NSW and 29% Australia-wide is of greatest concern, costing, on average, $7000 (AU) per inpatient episode.

The overarching aim of this study is to establish whether inpatient rehabilitation is necessary after TKR for patients with osteoarthritis (OA) who could otherwise be discharged directly home.

The main hypothesis to be tested by the proposed study is that TKR recipients who receive inpatient rehabilitation in addition to participating in a home programme, compared to patients who participate in a home programme only, will achieve a superior level of mobility. If superiority is shown, a cost-effectiveness analysis will be undertaken.

Secondary hypotheses to be tested relate to patient-reported knee pain and function, health-related quality of life, functional ambulation, and knee joint mobility.

Superiority in these outcomes will be evident at six months after surgery.

Description:

As preferences for therapy can be a confounder in RCTs, patients will be asked their preference for rehabilitation post TKR, prior to randomisation.

Patients will be randomised once a hospital bed is available.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Consecutive patients presenting for elective, primary, unilateral TKR at the Whitlam Joint Replacement Centre (Fairfield Hospital) will be screened for eligibility at the pre-admission clinic by the study Project Manager (PM).

• primary diagnosis of OA

Exclusion Criteria:

• predisposition for requiring prolonged inpatient supervision (eg requiring assistance with at least one personal activity of daily living or lack of social support)

• inability to comprehend the study protocol.

• catastrophic complication arising post-surgery which precludes rehabilitation commencing within 2-3 weeks of surgery

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Hospital Inpatient Rehabilitation
Those allocated to HI will be admitted to the adjacent rehabilitation hospital, Braeside Rehabilitation Hospital, for 10 days. As per the private sector, HI participants will receive twice-daily supervised physiotherapy comprising 1-1.5 hr class-based exercises and 1-1.5 hr one-to-one therapy. Prior to discharge, participants will be familiarised with the home programme as described in second arm. All participants will be required to complete a diary detailing programme adherence, healthcare utilisation, and social costs relating to carer-burden. Participants will attend the group-based sessions as per HO below for monitoring and progression of programme. An additional FIM outcome measure will be taken for this arm on admission and discharge from the inpatient rehab unit.
• Hybrid Home Programme (HO)
The HO will be based on what is standard care in the local health district and guidelines for exercise in the elderly and those with osteoarthritis. Approximately 2 weeks post-surgery, participants allocated to the HO will attend 1 group-based exercise session in the Physiotherapy Department (Fairfield Hospital) where the home programme will be rehearsed and exercises individualised as required due to co-morbidities. The programme comprises general aerobic components as well as general functional and muscle-specific exercises focused on restoring knee mobility, lower limb strength, and normal neuromuscular co-ordination and gait patterns. Participants will be able to return for 2-3 sessions over the 6-week period.

Locations

Country	Name	City	State
Australia	Braeside Hospital	Sydney	New South Wales
Australia	Fairfield Hospital	Sydney	New South Wales
Australia	Sutherland Hospital	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Mark Buhagiar	HammondCare

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking distance at 6 months post surgery, measured using the Six-Minute Walk Test (6MWT)	Functional mobility is a composite of several factors targeted in rehabilitation programs after TKA such as lower limb strength, knee range of motion, and balance. Second, a functional outcome is more likely to be directly influenced by the intervention (rehabilitation), and the intervention aims to improve walking. Third, the 6MWT is highly reproducible within the individual. Fourth, it is likely to be less susceptible to misinterpretation and less culturally sensitive than patient-reported outcomes. Fifth, the test does not appear to suffer from the floor or ceiling effects associated with many patient-reported outcomes. Sixth, an observer-measured outcome is less likely to be influenced by a preference effect compared to a patient-reported outcome, and this is particularly important when the intervention under examination cannot be blinded from the recipient. Together, these attributes mean the results for our primary outcome should be readily translatable to any TKA cohort.	Pre surgery; 10 weeks, six months and twelve months after surgery.	No
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS)		Pre surgery; 10 weeks, six months and twelve months after surgery.	No
Secondary	Knee range of motion		Pre surgery; 10 weeks, six months and twelve months after surgery.	No
Secondary	EQ5D	The EQ5D is a standardised measure providing a simple, generic measure of health. It looks at mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and provides a simple descriptive profile and a single index value for health status.	Pre surgery; 10 weeks, six months and twelve months after surgery.	No
Secondary	Cost of surgery	Itemised list of health service use, expenditure and days off work	Pre surgery; 10 weeks, six months and twelve months after surgery.	No
Secondary	Patient preference for therapy	Typical demographic and complication data (such as re-admission, re-operation, knee manipulation, death, venous thrombo-embolism, wound infection) will also be collected. As preferences for therapy can be a confounder in RCTs, patients will be asked their preference for rehabilitation post TKR prior to randomisation. Question may be 'What is your preference for rehab? Is it home based, inpatient or no preference?	After consenting to participation and prior to randomisation	No
Secondary	15 metre walk test		Pre surgery; 10 weeks, six months and twelve months after surgery.	No