The HIHO Study: Hospital Inpatient vs Home Rehabilitation After Total Knee Replacement (HIHO)
|ClinicalTrials.gov Identifier: NCT01583153|
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : April 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Other: Hospital Inpatient Rehabilitation Other: Hybrid Home Programme (HO)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomised Controlled Trial Comparing Hospital Inpatient vs Home Rehabilitation After Total Knee|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
|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.
- 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.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 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. ]
- 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.
- 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
- 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?
- 15 metre walk test [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583153
|Australia, New South Wales|
|Sydney, New South Wales, Australia, 2176|
|Sydney, New South Wales, Australia, 2176|
|Sydney, New South Wales, Australia, 2229|
|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|