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

NCT01583153 | Completed DMC

• 1 other identifier: HIHO-1042554
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre surgery; 10 weeks, six months and twelve months after surgery.

Secondary Outcomes (6)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Pre surgery; 10 weeks, six months and twelve months after surgery.

• Knee range of motion

  Pre surgery; 10 weeks, six months and twelve months after surgery.

• EQ5D

  Pre surgery; 10 weeks, six months and twelve months after surgery.

• Cost of surgery

  Pre surgery; 10 weeks, six months and twelve months after surgery.

• Patient preference for therapy

  After consenting to participation and prior to randomisation

Study Arms (2)

Hospital Inpatient Rehabilitation (HI)

ACTIVE COMPARATOR

Other: Hospital Inpatient Rehabilitation

Hybrid Home Programme (HO)

ACTIVE COMPARATOR

Other: Hybrid Home Programme (HO)

Interventions

Hospital Inpatient Rehabilitation OTHER

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.

Hospital Inpatient Rehabilitation (HI)

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.

Hybrid Home Programme (HO)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mark Buhagiar: lead
• HammondCare: collaborator

Study Sites (3)

Braeside Hospital

Sydney, New South Wales, 2176, Australia

Location

Fairfield Hospital

Sydney, New South Wales, 2176, Australia

Location

Sutherland Hospital

Sydney, New South Wales, 2229, Australia

Location

Related Publications (2)

• 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.

  PMID: 28291891 DERIVED

• 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.

  PMID: 24341348 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Manager of Allied Health, Principal Investigator

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 23, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

AU (3)