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

April 13, 2016 updated by: Mark Buhagiar

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2176
        • Fairfield Hospital
      • Sydney, New South Wales, Australia, 2176
        • Braeside Hospital
      • Sydney, New South Wales, Australia, 2229
        • Sutherland Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hospital Inpatient Rehabilitation (HI)
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.
Active Comparator: Hybrid Home Programme (HO)
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking distance at 6 months post surgery, measured using the Six-Minute Walk Test (6MWT)
Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery.
Pre surgery; 10 weeks, six months and twelve months after surgery.
Knee range of motion
Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery.
Pre surgery; 10 weeks, six months and twelve months after surgery.
EQ5D
Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery.
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.
Cost of surgery
Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery.
Itemised list of health service use, expenditure and days off work
Pre surgery; 10 weeks, six months and twelve months after surgery.
Patient preference for therapy
Time Frame: After consenting to participation and prior to randomisation
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
15 metre walk test
Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery.
Pre surgery; 10 weeks, six months and twelve months after surgery.

Collaborators and Investigators

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

Sponsor

Mark Buhagiar

Collaborators

HammondCare

Investigators

  • Principal Investigator: Justine M Naylor, PhD BAppSc(Phty), SWSLHD
  • Principal Investigator: Ian A Harris, PhD, MBBS, M Epi, SWSLHD
  • Principal Investigator: Friedbert Kohler, HammondCare
  • Principal Investigator: Mark Buhagiar, MHM BAppSc(Phty), HammondCare
  • Principal Investigator: Rachael Wright, BAppSc(OccThpy), SWSLHD
  • Principal Investigator: Renee Fortunato, B.App.Sc.(Phys.), SWSLHD
  • Principal Investigator: Wei Xuan, MSc MAppStat PhD, Ingham Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 19, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 23, 2012

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIHO-1042554

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.

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