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Trial registered on ANZCTR


Registration number
ACTRN12613000157774
Ethics application status
Approved
Date submitted
7/02/2013
Date registered
8/02/2013
Date last updated
27/09/2019
Date data sharing statement initially provided
27/09/2019
Date results provided
27/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of anterior cruciate ligament injury on skeletal muscle function, contractile proteins and inflammation
Scientific title
Skeletal muscle biopsy to evaluate Na+, K+, and ATPase content in young ACL injured participants
Secondary ID [1] 281917 0
Nil
Universal Trial Number (UTN)
U1111-1139-3325
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament injury 288314 0
Condition category
Condition code
Musculoskeletal 288669 288669 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
No drug intervention involved.
Muscle sample taken via muscle biopsy with a Bergstrom needle from the vastus lateralis of both injured and uninjured legs of patients undergoing ACL reconstructive surgery. The biopsy procedure takes less than 5 minutes on each leg.
Intervention code [1] 286481 0
Early detection / Screening
Comparator / control treatment
Muscle sample from the vastus lateralis of only the dominant leg using a Bergstrom needle in asymptomatic BMI and age matched controls.
Control group
Active

Outcomes
Primary outcome [1] 288818 0
Muscle Na+,K+ ATPase transport protein content. Measured using radioactive labelled ouabain binding site content for total functional Na+,K+ ATPase content, and western blotting for indivividual isoform content.
Timepoint [1] 288818 0
Immediately before the commencement of ACL reconstructive surgery.
Primary outcome [2] 288819 0
Muscle function (strength and balance). Isometric strength measured using a portable force transducer strapped to a chair at 90 degree knee flexion.

Balance will be assessed using a force platform which can calculate the average velocity of the participant's centre of pressure.
Timepoint [2] 288819 0
Approximately 1-2 weeks before ACL reconstructive surgery.
Secondary outcome [1] 301063 0
Muscle inflammatory factors (IL-6, TNF alpha). This will be assessed using a Multiplex suspension array system (Bio-Rad).
Timepoint [1] 301063 0
Immediately before ACL reconstructive surgery.

Eligibility
Key inclusion criteria
ACL group:
1. Scheduled for ACL reconstructive surgery.
2. Between 18-35 years of age
3. BMI <30

Control Group:
1. Free from lower limb injury
2. Between 18-35 years of age
3. BMI <30
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ACL group:
Not between 18-35 years of age.
Any metabolic or cardiovascular diseases which impact on physical activity prior to ACL injury.

Control group
Not between 18-35 years of age
Any metabolic or cardiovascular diseases which impact on physical activity levels
Recent lower limb joint injury

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No randomization or blinding of participants as those with ACL injury are undergoing a process to obtain a muscle sample in order to characterize biochemical effects on muscle due to ACL injury. Not a treatment intervention.

ACL injured group: Participants are approached by the researcher after they have set a date for ACL reconstructive surgery and asked if they would be interested in voluntary research investigating the muscular effects of ACL injury.

Controls: Asmyptomatic controls recruited from the student population at Victoria University.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation as explained above; not testing an any intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Control group recruited after ACL group to match BMI and age.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Strength, balance, and factors investigated in skeletal muscle will be compared via mixed linear modelling. This allows comparison between injured and uninjured legs, as well as between ACL injury and control participants. Pearson's correlation will be used to test association between strength and balance with muscle biochemical factors such as Na+/K+ ATPase.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/03/2013
Actual
4/03/2013
Date of last participant enrolment
Anticipated
Actual
1/12/2014
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
80
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 558 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment postcode(s) [1] 6297 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 286706 0
University
Name [1] 286706 0
Victoria University
Country [1] 286706 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Cnr. Ballarat and Gordon St
Footscray
Victoria
3011
Country
Australia
Secondary sponsor category [1] 285477 0
None
Name [1] 285477 0
Address [1] 285477 0
Country [1] 285477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288772 0
St. Vincent's Hospital Human Research Ethics Committee A
Ethics committee address [1] 288772 0
Ethics committee country [1] 288772 0
Australia
Date submitted for ethics approval [1] 288772 0
Approval date [1] 288772 0
29/10/2012
Ethics approval number [1] 288772 0
142/12
Ethics committee name [2] 288773 0
Victoria University Human Research Ethics Committee
Ethics committee address [2] 288773 0
Ethics committee country [2] 288773 0
Australia
Date submitted for ethics approval [2] 288773 0
Approval date [2] 288773 0
07/02/2013
Ethics approval number [2] 288773 0
12/343

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

Contacts
Principal investigator
Name 37702 0
Prof Michael McKenna
Address 37702 0
Professor Michael McKenna
Acting Director
Institute of Sport, Exercise and Active Living (ISEAL)
PO BOX 14428
Melbourne
VIC 8001
Country 37702 0
Australia
Phone 37702 0
61 3 9919 4499
Fax 37702 0
Email 37702 0
michael.mckenna@vu.edu.au
Contact person for public queries
Name 37703 0
Michael McKenna
Address 37703 0
Professor Michael McKenna
Acting Director
Institute of Sport, Exercise and Active Living (ISEAL)
PO BOX 14428
Melbourne
VIC 8001
Country 37703 0
Australia
Phone 37703 0
61 3 9919 4499
Fax 37703 0
Email 37703 0
michael.mckenna@vu.edu.au
Contact person for scientific queries
Name 37704 0
Michael McKenna
Address 37704 0
Professor Michael McKenna
Acting Director
Institute of Sport, Exercise and Active Living (ISEAL)
PO BOX 14428
Melbourne
VIC 8001
Country 37704 0
Australia
Phone 37704 0
61 3 9919 4499
Fax 37704 0
Email 37704 0
michael.mckenna@vu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Group results published in de-identified manner; See Perry et al., 2015 in Physiological Reports.


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
No additional documents have been identified.