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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01583153




Registration number
NCT01583153
Ethics application status
Date submitted
19/04/2012
Date registered
23/04/2012
Date last updated
14/04/2016

Titles & IDs
Public title
The HIHO Study: Hospital Inpatient vs Home Rehabilitation After Total Knee Replacement
Scientific title
Randomised Controlled Trial Comparing Hospital Inpatient vs Home Rehabilitation After Total Knee
Secondary ID [1] 0 0
HIHO-1042554
Universal Trial Number (UTN)
Trial acronym
HIHO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Hospital Inpatient Rehabilitation
Other interventions - Hybrid Home Programme (HO)

Active Comparator: Hospital Inpatient Rehabilitation (HI) -

Active Comparator: Hybrid Home Programme (HO) -


Other interventions: 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.

Other interventions: 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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Pre surgery; 10 weeks, six months and twelve months after surgery.
Secondary outcome [1] 0 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 0 0
Pre surgery; 10 weeks, six months and twelve months after surgery.
Secondary outcome [2] 0 0
Knee range of motion
Timepoint [2] 0 0
Pre surgery; 10 weeks, six months and twelve months after surgery.
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Pre surgery; 10 weeks, six months and twelve months after surgery.
Secondary outcome [4] 0 0
Cost of surgery - Itemised list of health service use, expenditure and days off work
Timepoint [4] 0 0
Pre surgery; 10 weeks, six months and twelve months after surgery.
Secondary outcome [5] 0 0
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?
Timepoint [5] 0 0
After consenting to participation and prior to randomisation
Secondary outcome [6] 0 0
15 metre walk test
Timepoint [6] 0 0
Pre surgery; 10 weeks, six months and twelve months after surgery.

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Braeside Hospital - Sydney
Recruitment hospital [2] 0 0
Fairfield Hospital - Sydney
Recruitment hospital [3] 0 0
Sutherland Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2176 - Sydney
Recruitment postcode(s) [2] 0 0
2229 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Mark Buhagiar
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
HammondCare
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT01583153
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Justine M Naylor, PhD BAppSc(Phty)
Address 0 0
SWSLHD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications