OsteoarthritisHIHONCT01583153
The HIHO Study: Hospital Inpatient vs Home Rehabilitation After Total Knee Replacement
A study testing Hospital Inpatient Rehabilitation and Hybrid Home Programme (HO) in people with Osteoarthritis, run by Mark Buhagiar at 3 sites in Australia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hospital Inpatient Rehabilitation and Hybrid Home Programme (HO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 3 sitesAustralia
- Study dates
- Jun 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Braeside Hospital
Sydney, New South Wales, 2176
Fairfield Hospital
Sydney, New South Wales, 2176
Sutherland Hospital
Sydney, New South Wales, 2229
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Hospital Inpatient Rehabilitation, Hybrid Home Programme (HO)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Inpatient RehabilitationOther
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Hospital Inpatient Rehabilitation (HI) | Active comparator | Not described Receives: Other: Hospital Inpatient Rehabilitation |
| Hybrid Home Programme (HO) | Active comparator | Not described Receives: Other: Hybrid Home Programme (HO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre surgery; 10 weeks, six months and twelve months after surgery.
Secondary outcomes (6)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: Pre surgery; 10 weeks, six months and twelve months after surgery.
Knee range of motion
Measured: Pre surgery; 10 weeks, six months and twelve months after surgery.
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.
Measured: Pre surgery; 10 weeks, six months and twelve months after surgery.
Cost of surgery
Itemised list of health service use, expenditure and days off work
Measured: Pre surgery; 10 weeks, six months and twelve months after surgery.
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?
Measured: After consenting to participation and prior to randomisation
15 metre walk test
Measured: Pre surgery; 10 weeks, six months and twelve months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Buhagiar
- Sponsor type
- University, hospital or other
- Collaborators
- HammondCare
- Responsible party
- Sponsor-investigator, Mark Buhagiar, South West Sydney Local Health District
- Investigators
- Justine M Naylor, PhD BAppSc(Phty), Principal investigator, SWSLHDIan A Harris, PhD, MBBS, M Epi, Principal investigator, SWSLHDFriedbert Kohler, Principal investigator, HammondCareMark Buhagiar, MHM BAppSc(Phty), Principal investigator, HammondCareRachael Wright, BAppSc(OccThpy), Principal investigator, SWSLHDRenee Fortunato, B.App.Sc.(Phys.), Principal investigator, SWSLHDWei Xuan, MSc MAppStat PhD, Principal investigator, Ingham Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583153
- Sponsor's protocol ID
- HIHO-1042554
- Acronym
- HIHO
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2012
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, Wright R, Fortunato R. Effect of Inpatient Rehabilitation vs a Monitored Home-Based Program on Mobility in Patients With Total Knee Arthroplasty: The HIHO Randomized Clinical Trial. JAMA. 2017 Mar 14;317(10):1037-1046. doi: 10.1001/jama.2017.1224.
PubMed 28291891Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, Wright RJ, Fortunato R. Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial. Trials. 2013 Dec 17;14:432. doi: 10.1186/1745-6215-14-432.
PubMed 24341348
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing Hospital Inpatient vs Home Rehabilitation After Total Knee
- ClinicalTrials.gov ID
- NCT01583153
- Acronym / sponsor ID
- HIHO / HIHO-1042554
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Mark BuhagiarUniversity, hospital or other
- Collaborators
- HammondCare
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital Inpatient Rehabilitation (HI) | Active comparator | Other: Hospital Inpatient Rehabilitation |
| Hybrid Home Programme (HO) | Active comparator | Other: Hybrid Home Programme (HO) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital Inpatient RehabilitationThose 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 | Hospital Inpatient Rehabilitation (HI) |
| 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. | Other | Hybrid Home Programme (HO) |
Primary outcome
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.
6 secondary outcomes
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.
Cost of surgery
Time frame: 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
15 metre walk test
Time frame: Pre surgery; 10 weeks, six months and twelve months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Derived from this study: PubMed 28291891Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, Wright R, Fortunato R. Effect of Inpatient Rehabilitation vs a Monitored Home-Based Program on Mobility in Patients With Total Knee Arthroplasty: The HIHO Randomized Clinical Trial. JAMA. 2017 Mar 14;317(10):1037-1046. doi: 10.1001/jama.2017.1224.
- Derived from this study: PubMed 24341348Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, Wright RJ, Fortunato R. Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial. Trials. 2013 Dec 17;14:432. doi: 10.1186/1745-6215-14-432.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justine M Naylor, PhD BAppSc(Phty) principal investigator
SWSLHD
Ian A Harris, PhD, MBBS, M Epi principal investigator
SWSLHD
Friedbert Kohler principal investigator
HammondCare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital Inpatient Rehabilitation and Hybrid Home Programme (HO) in people with Osteoarthritis, run by Mark Buhagiar at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01583153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.