Clinical trial NCT01583153: The HIHO Study: Hospital Inpatient vs Home Rehabilitation After Total Knee Replacement
Official title: Randomised Controlled Trial Comparing Hospital Inpatient vs Home Rehabilitation After Total Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: South West Sydney Local Health District
Sponsor class: OTHER
Collaborators: name: HammondCare
First posted: 2012-04-23
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Walking distance at 6 months post surgery, measured using the Six-Minute Walk Test (6MWT)
timeFrame: Pre surgery; 10 weeks, six months and twelve months after surgery.
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Pre surgery; 10 weeks, six months and twelve months after surgery.
measure: Knee range of motion
timeFrame: Pre surgery; 10 weeks, six months and twelve months after surgery.
measure: EQ5D
timeFrame: Pre surgery; 10 weeks, six months and twelve months after surgery.
measure: Cost of surgery
timeFrame: Pre surgery; 10 weeks, six months and twelve months after surgery.
measure: Patient preference for therapy
timeFrame: After consenting to participation and prior to randomisation
measure: 15 metre walk test
timeFrame: Pre surgery; 10 weeks, six months and twelve months after surgery.
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Braeside Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Fairfield Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sutherland Hospital
state: New South Wales
Study officials:
affiliation: SWSLHD
name: Justine M Naylor, PhD BAppSc(Phty)
role: PRINCIPAL_INVESTIGATOR
affiliation: SWSLHD
name: Ian A Harris, PhD, MBBS, M Epi
role: PRINCIPAL_INVESTIGATOR
affiliation: HammondCare
name: Friedbert Kohler
role: PRINCIPAL_INVESTIGATOR
affiliation: HammondCare
name: Mark Buhagiar, MHM BAppSc(Phty)
role: PRINCIPAL_INVESTIGATOR
affiliation: SWSLHD
name: Rachael Wright, BAppSc(OccThpy)
role: PRINCIPAL_INVESTIGATOR
affiliation: SWSLHD
name: Renee Fortunato, B.App.Sc.(Phys.)
role: PRINCIPAL_INVESTIGATOR
affiliation: Ingham Institute
name: Wei Xuan, MSc MAppStat PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Buhagiar 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.