Trial Review

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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] 280157 0
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 286079 0
Condition category
Condition code
Musculoskeletal 286275 286275 0 0
Osteoarthritis
Surgery 286791 286791 0 0
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] 284483 0
Rehabilitation
Intervention code [2] 284911 0
Prevention
Comparator / control treatment
The control group will recieve no exercise training.
Control group
Active

Outcomes
Primary outcome [1] 286742 0
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] 286742 0
Baseline and 12 weeks following neuromuscular exercise intervention
Secondary outcome [1] 296565 0
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] 296565 0
Baseline and follow-up (12 weeks)
Secondary outcome [2] 296566 0
Functional performance for: single-leg rise, hop for distance and 30 second knee bends
Timepoint [2] 296566 0
Baseline and follow-up (12 weeks)
Secondary outcome [3] 296567 0
Muscle Strength: 1) knee extensor and flexors (isokinetic dynamometer) and 2) hip adductors and abductors (hand-held dynamometer)
Timepoint [3] 296567 0
Baseline and follow-up (12 weeks)
Secondary outcome [4] 296568 0
Self-Reported Outcomes: Knee Osteoarthritis Outcome Score
Timepoint [4] 296568 0
Baseline and Follow-up (12 weeks)
Secondary outcome [5] 300021 0
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] 300021 0
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?
No
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
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284907 0
Government body
Name [1] 284907 0
National Health Medical Research Council
Country [1] 284907 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Victoria
AUSTRALIA 3010
Country
Australia
Secondary sponsor category [1] 283783 0
None
Name [1] 283783 0
Address [1] 283783 0
Country [1] 283783 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286904 0
The University of Melbourne
Ethics committee address [1] 286904 0
Ethics committee country [1] 286904 0
Australia
Date submitted for ethics approval [1] 286904 0
13/04/2012
Approval date [1] 286904 0
23/04/2012
Ethics approval number [1] 286904 0
1137168
Ethics committee name [2] 287255 0
Behavioural and Social Sciences Human Ethics Sub-Commitee
Ethics committee address [2] 287255 0
Ethics committee country [2] 287255 0
Australia
Date submitted for ethics approval [2] 287255 0
Approval date [2] 287255 0
24/04/2012
Ethics approval number [2] 287255 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33934 0
Address 33934 0
Country 33934 0
Phone 33934 0
Fax 33934 0
Email 33934 0
Contact person for public queries
Name 17181 0
Professor Kim Bennell
Address 17181 0
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 17181 0
Australia
Phone 17181 0
+ 61 3 83444135
Fax 17181 0
Email 17181 0
[email protected]
Contact person for scientific queries
Name 8109 0
Professor Kim Bennell
Address 8109 0
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 8109 0
Australia
Phone 8109 0
+ 61 3 83444135
Fax 8109 0
Email 8109 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23213Study protocolHall 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.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3932Plain language summaryNo Although the exercise program resulted in overall ... [More Details]
4349Study results articleYes Hall M, Hinman RS, Wrigley TV, Roos EM, Staples M,... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNeuromuscular Exercise post Partial Medial Meniscectomy: Randomized Controlled Trial.2015https://dx.doi.org/10.1249/MSS.0000000000000596
N.B. These documents automatically identified may not have been verified by the study sponsor.