ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000167965

Ethics application status

Approved

Date submitted

23/07/2010

Date registered

11/02/2011

Date last updated

11/02/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

Rehabilitation after elective total hip replacement.

Scientific title

Comparison of structured physiotherapy rehabilitation with an unsupervised home exercise program after elective total hip replacement surgery for optimal patient recovery.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Total hip replacement

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Osteoarthritis

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

2 groups:

Group 2: Independent home exercise program (reliant on pt compliance)
This group is designed to investigate whether physiotherapy led rehabiltation is required post THR.
Standard post THR ex program provided to all patients, instructed to continue these 3x daily independently as per in hospital ad to continue on discharge from hospital; exs focus on lower limb ROM & strengthing.
Patients choose to follow instructions on ex sheet which are as follows (time frame for completion of each session is patient dependent; 6 exs min x10 reps till 3 months then 8 exs recommended):
- You must exercise at least 3 times daily. Repeat each exercise slowly at least 5-10 times.
-Exercises 3 to 8 should be continued following discharge from hospital. Exercise 9-10 can be commenced at 3 months.
The exercises are indicated on the sheet to continue till 3months and then an additional two exercises are shown that are able to be commenced after 3 months but their is no emphasis for how long the program needs to continue post 3 months.
The re assessment intervals do continue till 6 months ( 5, 12 & 26 wks as documented)

Intervention code [1]

Rehabilitation

Comparator / control treatment

Group 1: Supervised exercise class (Standard care)
Provided in group setting led by physiotherapist
Circuit program 60min involving lower limb strengthening, ROM & gait retraining stations
Offered 2x wk/4wks,to commence by next available session after hospital discharge
Max class participants 12

Control group

Active

Outcomes

Primary outcome [1]

Quality of Life by the Short form 36 questionnaire (SF36)

Timepoint [1]

Pre operatively, 5, 12 , & 26 weeks post operatively

Primary outcome [2]

Self reported Hip function by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Timepoint [2]

Pre operatively, 5, 12, & 26 weeks post operatively

Secondary outcome [1]

Mobility by the Timed Up and Go Test (TUG)

Timepoint [1]

Pre operatively, 5, 12, & 26 weeks post operatively

Eligibility

Key inclusion criteria

1. Have had an elective total hip replacement.
2. Be able to full weight bear post operatively/ weight bear as tolerated.
3. Reside within the normal service provision area post operatively.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Total hip replacement surgery for metastatic disease, pathological fractures, infection or acute trauma.
2. Revision total hip replacement surgery.
3. Inability to provide informed consent due to poor understanding of explanation and unable to follow independently a home exercise program.
4. University of California, Los Angeles (UCLA) activity level < 2 pre operatively.
5. Persons under the age of 18.
6. Inabliity to provide informed consent.

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)

Participants will be identified at their pre admission clinic appointment if they want to participate by the interviewing nurse.
The senior orthopaedic physiotherapist will then be available to explain the study, recruit the patient and complete consent. Following consent participants will be asked to complete several forms and receive the patient information sheet.
Following their surgery, in hospital physiotherapy and care will proceed according to the standard protocols.
When the participant is ready for discharge they will be assigned to intervention group 1 or 2 by opening of a randomisation envelope.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be by permuted blocks to assist with maintaining equivalent sample size in both groups.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/04/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

120

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian National University

Address [1]

ANU College of Medicine, Biology & Environmemt
The John Curtin School of Medical Research
The Australian National University
Canberra ACT 0200

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Canberra Hospital

Address

Trauma and Orthopaedic Research Unit
Building 6, Level 1
Canberra Hospital
Garran ACT 2605

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Australian National University

Address [1]

Canberra, ACT 2600

Country [1]

Australia

Other collaborator category [1]

Hospital

Name [1]

The Canberra Hospital - Physiotherapy Department

Address [1]

Physiotherapy Department
Canberra Hospital
PO Box 11
Woden ACT 2606

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ACT Health Human Research Ethics Committee

Ethics committee address [1]

11 Moore St
Canberra City
ACT 2601

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/02/2010

Ethics approval number [1]

ETH.8/09.795

Ethics committee name [2]

Australian National University Human Ethics Committee

Ethics committee address [2]

Office of Research Integrity,
Research Office,
Level 3, Innovations Bldg
124 Eggleston Rd
The Australian National University
ACTON ACT 0200

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

28/05/2010

Ethics approval number [2]

2010/036

Summary

Brief summary

Rehabilitation after total hip replacement is important for recovery; at the Canberra hospital physiotherapy provides this rehabilitation.  As physiotherapists we don’t know yet how long, what kind or when rehabilitation is most effective. Our own survey showed that only 50% of Australian hospitals offer rehabilitation for hip replacements at all. 
The project aims to see how effective rehabilitation is by measuring patient outcomes after their total hip replacement surgery. 
This is a randomised controlled trial with division into two groups after total hip replacement. Group one will receive rehabilitation in the form of the current supervised exercise class and group two will receive a home exercise program to be performed independently. 
We hypothesise that rehabilitation provided via a home based exercise program without formal supervision after hospital discharge, relying on patient compliance, will produce similar outcomes to those produced by the current method of rehabilitation for total hip replacement patients after hospital discharge, which is that of a centre based program with formal supervision.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Corinne Coulter

Address

Physiotherapy Department
Canberra Hospital
PO Box 11
Woden ACT 2606

Country

Australia

Phone

+61 2 62442154

Fax

corinne.coulter@act.gov.au

Contact person for scientific queries

Name

Dr Jennie Scarvell

Address

Trauma and Orthopaedic Research Unit
Clinical Research Coordinator
Buidling 6, Level 1
Canberra Hospital
PO Box 11
Woden ACT 2606

Country

Australia

Phone

+61 2 6244 3701

Fax

+61 2 6201 2157

jennie.scarvell@act.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Supervised and Independent Post-Discharge Rehabilitation Did Not Differ for Improving Pain and Function After Unilateral Total Hip Replacement.	2018	https://dx.doi.org/10.2106/JBJS.18.00633

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically