ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000542897

Ethics application status

Approved

Date submitted

21/05/2012

Date registered

22/05/2012

Date last updated

19/11/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of neuromuscular training post-arthroscopic partial meniscectomy on medial knee joint loading: a randomised, controlled trial.

Scientific title

The effect of neuromuscular training post-arthroscopic partial meniscectomy on medial knee joint loading: a randomised, controlled trial.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1129-1829

Trial acronym

SCOPEX

Linked study record

Health condition

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

Arthroscopic partial medial meniscectomy

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Neuromuscular Program: Experienced musculoskeletal physiotherapists will deliver the exercise program. A total of eight treatments will be delievered over twelve weeks; two treatments sessions in week one, once in the second and third weeks and fortnightly thereafter. The duration of the first session will be 45 minutes with the remaining sessions lasting 30 minutes. The physiotherapists will individualise the neuromuscular program to the ability of each participant. In addition to attending the phyisotherapist, participants will perform 5-6 exercises that will last 30-35min, 3 times each week unsupervised, at home for the 12 week period.

Intervention code [1]

Rehabilitation

Intervention code [2]

Prevention

Comparator / control treatment

The control group will recieve no exercise training.

Control group

Active

Outcomes

Primary outcome [1]

The external peak knee adduction moment (KAM) during normal pace walking and single-leg rise. The KAM will be measured using 3-dimensional movement analysis.

Timepoint [1]

Baseline and 12 weeks following neuromuscular exercise intervention

Secondary outcome [1]

Muscle activation patterns using electromyography. The primary muscles of interest include vastus lateralis, vastus medialis, rectus femoris, medial and lateral hamstrings. We will also collect data on the gluteus medius and medial and lateral gastrocnemius.

Timepoint [1]

Baseline and follow-up (12 weeks)

Secondary outcome [2]

Functional performance for: single-leg rise, hop for distance and 30 second knee bends

Timepoint [2]

Baseline and follow-up (12 weeks)

Secondary outcome [3]

Muscle Strength: 1) knee extensor and flexors (isokinetic dynamometer) and 2) hip adductors and abductors (hand-held dynamometer)

Timepoint [3]

Baseline and follow-up (12 weeks)

Secondary outcome [4]

Self-Reported Outcomes: Knee Osteoarthritis Outcome Score

Timepoint [4]

Baseline and Follow-up (12 weeks)

Secondary outcome [5]

Peak KAM during fast-pace walking and hop for distance and KAM impulse during walking (normal pace and fast pace), single-leg rise and hop for distance.

Timepoint [5]

Baseline and Follow-up (12 weeks)

Eligibility

Key inclusion criteria

a) Aged between 30-50 years old; b) a primary arthroscopic partial medial meniscectomy between 3-12 months ago

Minimum age

30 Years

Maximum age

50 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

a) in the past week an average overall pain greater than or equal to 3 out of 10 on an 11 point numerical rating scale; b) signs of moderate or severe knee osteoarthritis on x-ray(Kellgren & Lawrence Grades 3 or 4); c) full tears of the knee anterior or posterior cruciate ligaments; d) anterior or posterior cruciate ligaments reconstructions; e) back or lower extremity pain (other than the affected knee) that limited everyday activities or required treatment in the past month; f) history of lower limb surgery (other than arthroscopy); g) other forms of arthritis, diabetes cardiac, circulatory conditions that limit everyday activities; h) neurological conditions; i) a body mass index >34; j) any ailment precluding safe participation in exercise; k) inadequate written or spoken English; l) high levels of physical activity defined as participation in organised team or individual sport that requires regular competition and requires some form of systematic training

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)

Potentially eligible participants will be identified through orthopaedic surgeon's patient records. These eligible patients will receive a letter of information and the plain language statement. If the person is eligible the researcher will obtain written informed consent and invite the participant to have an x-ray of their knee. However, no x-ray will be required if individuals can provide us with a knee x-ray from the past 12 months. If the x-ray does not show signs of moderate to severe knee osteoarthritis, the participant will be enrolled into the study and scheduled for baseline testing.
Following baseline assessment participants will be consecutively randomised into the neuromuscular exercise group or the control group.

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

A researcher with no additional involvement in the study will prepare consecutively numbered, sealed, opaque envelopes containing group allocation. Treatment group allocation will be stratified for gender and randomised within random permuted blocks generated a priori using Excel’s random number generator

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/06/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health Medical Research Council

Address [1]

National Health Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

The University of Melbourne
Victoria
AUSTRALIA 3010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Melbourne

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/04/2012

Approval date [1]

23/04/2012

Ethics approval number [1]

1137168

Ethics committee name [2]

Behavioural and Social Sciences Human Ethics Sub-Commitee

Ethics committee address [2]

Melbourne Research,
Level 5, Alan Gilbert Building,
161 Barry St. (corner of Grattan and Barry Sts)
CARLTON VIC 3053

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

24/04/2012

Ethics approval number [2]

Summary

Brief summary

Knee osteoarthritis is a common musculoskeletal condition that is increasingly prevalent as the population ages. Knee osteoarthritis research has largely focused on treating pain and disability. However, to reduce the incidence of this burdensome disease, prevention is also vital. Individuals who have undergone an arthroscopic partial meniscectomy (APM), a common surgical procedure to repair, remove or trim the inner knee meniscus are at increased risk to develop knee osteoarthritis. Post-APM patients, have increased knee joint loading as compared to matched healthy individuals. It is widely accepted that increased knee joint loads may be one factor related to the initiation and progression of knee osteoarthritis. In young healthy individuals neuromuscular exercises can reduce knee joint loading during athletic tasks however, the effects of neuromuscular exercises on knee joint loads are unclear in those considered at high risk of developing early knee osteoarthritis. This research will primarily investigate the effects of a neuromuscular exercise program on knee load in those who have undergone an arthroscopy to repair, remove or trim the inner knee meniscus. The neuromuscular intervention includes exercises designed to improve co-ordination, knee alignment and balance. This study will help us to develop better rehabilitation programs that could help delay the onset of knee osteoarthritis following knee arthroscopy.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Kim Bennell

Address

Centre for Health, Exercise and Sports Medicine
Melbourne School of Health Science
Department of Physiotherapy
Level 1, 200 Berkeley St
The University of Melbourne
Victoria 3010
Australia

Country

Australia

Phone

+ 61 3 83444135

Fax

k.bennell@unimelb.edu.au

Contact person for scientific queries

Name

Professor Kim Bennell

Address

Centre for Health, Exercise and Sports Medicine
Melbourne School of Health Science
Department of Physiotherapy
Level 1, 200 Berkeley St
The University of Melbourne
Victoria 3010
Australia

Country

Australia

Phone

+ 61 3 83444135

Fax

k.bennell@unimelb.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23213	Study protocol	Hall M, Hinman RS, Wrigley TV, Roos EM, Staples M, Hodges PW, Staples M, Bennell KL. The effect of neuromuscular exercise on medial knee joint load post-arthroscopic partial medial meniscectomy: a randomized control trial protocol. BMC Musculoskeletal Disorders 2012;13.

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
3932	Plain language summary	No		Although the exercise program resulted in overall ... [More Details]
4349	Study results article	Yes		Hall M, Hinman RS, Wrigley TV, Roos EM, Staples M,... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Neuromuscular Exercise post Partial Medial Meniscectomy: Randomized Controlled Trial.	2015	https://dx.doi.org/10.1249/MSS.0000000000000596

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

Trial Review

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Documents added automatically