ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000190606

Ethics application status

Approved

Date submitted

13/02/2014

Date registered

21/02/2014

Date last updated

1/04/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

Short term benefits of prehabilitation for Total Knee Joint Replacement (TKJR)

Scientific title

For people undergoing total knee joint replacement, does undergoing prehabilitation lead to better short term outcomes compared to not undergoing prehabilitation?

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1153-3082

Trial acronym

Linked study record

Health condition

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

Total Knee Joint Replacement

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Prehabilitation consists of at least 4 (and maximum 8) physiotherapy sessions prior to TKJR surgery. The prehabilitation sessions consist of exercises aimed at increasing strength and range of motion about the knee. Education regarding the processes and expectations following a TKJR are discussed and participants practice using pick up frames and crutches to increase familiarity with methods of mobilising post surgery. The sessions are aimed at improving overall fitness, mobility, strength and confidence leading into having TKJR surgery.

Prehabilitation will aim to be 2 sessions per week for 4 weeks prior to surgery, with each session lasting 30-45 minutes (depending on progress in each session).

Intervention code [1]

Rehabilitation

Comparator / control treatment

Usual practice prior to TKJR surgery (i.e. no physiotherapist led intervention)

Control group

Active

Outcomes

Primary outcome [1]

Time until ready for discharge from physiotherapy.

Timepoint [1]

Post surgery, the treating physiotherapist will assess the participant each day as part of routine practice. When the appropriate assessments reach the required level the patient will be considered ready for discharge from physiotherapy.

Secondary outcome [1]

Length of stay

Timepoint [1]

Length of stay will be assessed at discharge (i.e. time from surgery to discharge)

Secondary outcome [2]

Knee Osteoarthritis Outcome Score (KOOS)

Timepoint [2]

Discharge and 3 months post discharge

Eligibility

Key inclusion criteria

Patients undergoing an elective TKJR at St Vincent's Private Hospital in Kew, Victoria, Australia..

Minimum age

40 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Bilateral TKJR’s/Unicompartmental Knee Replacements (UKR)
UKR
Significant co-morbidities likely to affect recovery from surgery i.e chronic condition – COPD, MS, Cardiac Condition, severe mental illness, ID, Alzhemier’s.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Subjects are invited to participate at a pre-admission appointment. Subjects nominate whether they choose to undergo prehabilitation or not. This is usual practice at the hospital where the trial will be undertaken.

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

N/A

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Subjects nominate whether they will undertake the intervention or not. This is in line with usual practice at the hospital where the trial will take place.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Comparison of the rehabilitation and non-prehabilitation groups mean time to readiness for discharge, comparison of the mean length of stay between same groups, comparison of mean KOOS scores on discharge and 3 months later. In order to detect a difference of 0.5 days, with a SD of 3 days, 46 participants are needed per group to detect a difference with 95% confidence and 80% power. To allow for drop outs this number has been rounded up to 100.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

10/03/2014

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Private Hospital - Fitzroy

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Unfunded

Address [1]

Unfunded

Country [1]

Primary sponsor type

University

Name

Monash University

Address

Department of Physiotherapy
Faculty of Medicine, Nursing and Health Sciences
Peninsula Campus, Monash University
McMahons Rd
Frankston
Vic 3199

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Low Risk Research Sub-committee of Human Research Ethics Committee (HREC-A)

Ethics committee address [1]

41 Victoria Parade
Fitzroy
Vic 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/02/2014

Ethics approval number [1]

LRR153/13

Summary

Brief summary

A Total Knee Replacement (TKJR) is a common treatment for advanced osteoarthritis of the knee. Osteoarthritis is the wearing of the joint surfaces in the knee, over time becoming painful and severely limiting a person’s mobility. In a TKJR, worn joint surfaces of the knee are replaced with synthetic components, removing the source of pain and allowing a person to return to higher levels of function.  However, the nature of the surgery means rehabilitation is required to allow the person to return to previous levels of activity.
A TKJR is an elective procedure with a long wait list in the public hospital system. Individuals with private health insurance can avoid a long wait for surgery and have the procedure conducted in a private hospital, with insurance covering the majority of the costs for surgery. Private health insurance also commonly covers some of the costs associated with physiotherapy treatment and rehabilitation. 
Prehabilitation is the practice of exercising prior to a procedure to increase the strength and function of the body in order to speed up recovery after surgery. In the case of a TKJR, prehabilitation equates to increasing knee joint flexion, increasing strength in the muscles around the knee and improving general cardiovascular fitness. The ultimate aim of prehabilitation is to speed the recovery after surgery through the strengthening of major muscles groups beforehand. 
It is current practice at St Vincent's Private, Kew, that patients undergoing a TKJR are given the option to undertake prehabilitation or not. This research aims to determine whether prehabilitation in a private hospital setting improves short -term outcomes after TKJR.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Ross Iles

Address

Department of Physiotherapy
Faculty of Medicine, Nursing and Health Sciences
Peninsula Campus, Monash University
McMahons Rd
Frankston
Vic 3199

Country

Australia

Phone

+61 3 99044119

Fax

ross.iles@monash.edu

Contact person for public queries

Name

Ross Iles

Address

Department of Physiotherapy
Faculty of Medicine, Nursing and Health Sciences
Peninsula Campus, Monash University
McMahons Rd
Frankston
Vic 3199

Country

Australia

Phone

+61 3 99044119

Fax

ross.iles@monash.edu

Contact person for scientific queries

Name

Ross Iles

Address

Department of Physiotherapy
Faculty of Medicine, Nursing and Health Sciences
Peninsula Campus, Monash University
McMahons Rd
Frankston
Vic 3199

Country

Australia

Phone

+61 3 99044119

Fax

ross.iles@monash.edu

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			365798-(Uploaded-18-11-2019-09-27-41)-Basic results summary.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

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