Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001300561p
Ethics application status
Submitted, not yet approved
Date submitted
11/04/2024
Date registered
25/10/2024
Date last updated
25/10/2024
Date data sharing statement initially provided
25/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Why young females develop old knees: examining joint mechanics in females returning to sport following anterior cruciate ligament reconstruction
Scientific title
Why young females develop old knees: examining joint mechanics in females returning to sport following anterior cruciate ligament reconstruction
Secondary ID [1] 311935 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament reconstruction 333526 0
Condition category
Condition code
Musculoskeletal 330205 330205 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a feasibility study that aims to pilot cutting-edge computational modelling methods of knee cartilage load and anterior cruciate ligament (ACL) force in 15 post-pubertal females (aged 18-25) having undergone ACL reconstruction (ACLR) 9-12 months prior (typical return-to-sport timeframe) and 15 age-matched female controls with no history of knee or lower limb injury. The interventional component of the study will examine the effects of three footwear conditions (i.e., barefoot plus two shod) on knee cartilage/ACL force in the two cohorts (i.e., ACLR and healthy controls) during several sports-related tasks.
A comprehensive biomechanical data collection protocol consisting of three-dimensional (3D) motion capture, electromyography (EMG), ground reaction forces and plantar pressure (shod conditions) will be performed as participants complete eight tasks common to ACLR rehabilitation and return-to-sport testing. The tasks will be performed barefoot in order of physical demand: 1. Moderate-paced walking (1.4 m/s), 2. Moderate-paced running (4.0 m/s), 3. Single leg squat to plinth, 4. Double leg countermovement jump, 5. Single leg land off small box, 6. Single leg countermovement jump, 7. Drop land lateral jump, and 8. 45 degree cutting (anticipated and unanticipated). Three repetitions will be performed for each task which will take approximately five minutes to complete. Participants will be required to rest for two-minutes between tasks (time required = 48mins). In addition to barefoot, all participants will be asked to perform tasks #7 and #8 in two different footwear conditions (i.e., athletic shoe with 7mm heel pitch with and without a full-length medial wedged insole) in a randomized order. An additional ~26 mins will be required to complete the second part of the test protocol (i.e., 2 tasks of 5 mins duration plus 2 mins rest between tasks multipled by 2 footwear conditions). As such, the total test time per participant will be approximately 74 mins. Because the footwear intervention will be conducted within the same test session, there is no need to monitor adherence.
A research physiotherapist with PhD qualifications will lead and supervise each test session. Other research physiotherapists, biomechanists, research assistants and a research higher degree student will be involved in the data collection process.
Intervention code [1] 328395 0
Prevention
Intervention code [2] 328396 0
Treatment: Devices
Comparator / control treatment
Age-matched female control participants will be recruited from University of Melbourne sports clubs and other local sporting communities. These individuals will have no history of serious knee/ACL injury.
Control group
Active

Outcomes
Primary outcome [1] 337959 0
Knee cartilage load.
Timepoint [1] 337959 0
9-12 months post ACLR; intervention conducted within the same test session.
Primary outcome [2] 339665 0
Anterior cruciate ligament force
Timepoint [2] 339665 0
9-12 months post ACLR; intervention conducted within the same test session.
Secondary outcome [1] 440817 0
Self-reported knee pain, other symptoms, function in daily living, function in sport and recreation, knee-related quality of life over the past week.
Timepoint [1] 440817 0
9-12 months post ACLR; intervention conducted within the same test session.

Eligibility
Key inclusion criteria
Inclusion criteria for the clinical cohort include:
-Female sex aged between 18-25 having undergone ACLR for an acute unilateral ACL rupture
-Recently cleared (<1 month) by their treating orthopaedic surgeon to commence sporting tasks
-Prior to their knee injury regularly (once or more per week) performing running, cutting, pivoting, and decelerating during sport as determined by MARS scoring (i.e., scores of 2 or more for each sub-scale)

Inclusion criteria for healthy control group include:
-Female sex aged between 18-25
-Currently involved in running, cutting, pivoting, and decelerating sporting movements at least once per week as determined by MARS scoring (i.e., scores of 2 or more for each sub-scale)

Minimum age
18 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for criteria for the clinical cohort include:
-Previous ACL surgeries to either limb.
-Other musculoskeletal or neurological condition impacting sporting tasks
-Unable or unwilling to undergo MRI
-Unable or unwilling to attend the University of Melbourne Department of Physiotherapy gait laboratory for a 2.5 hour testing session
-Unable to fit in standard width shoes

Exclusion criteria for healthy control group include:
Previous knee surgeries to either limb.
-Other musculoskeletal or neurological condition impacting current sporting tasks
-Unable or unwilling to undergo MRI
-Unable or unwilling to attend the University of Melbourne Department of Physiotherapy gait laboratory for a 2.5-hour testing session
-Unable to fit in standard width shoes

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics (i.e. means and standard deviations) will be used to summarise participant group characteristics and self- reported measures.
To address to our research questions:
1. Correlations between the localization of peak cartilage pressure and magnetic resonance imaging (MRI) Osteoarthritis Knee Score scores will be made using Pearson’s correlation coefficients. Correlations between the localization of peak cartilage pressure and quantitative 3D segmentations of BMLs and cartilage will be made using statistical parametric mapping.
2. Between group comparisons for knee cartilage pressure and anterior cruciate ligament (ACL) force for each task will be made using linear regression accounting for covariates.
3. To assess the immediate effect of footwear condition a linear statistical model (i.e., repeated measures MANOVA) will be used to assess differences in peak cartilage contact pressure and ACL force between conditions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2025
Actual
Date of last participant enrolment
Anticipated
5/01/2026
Actual
Date of last data collection
Anticipated
19/01/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26389 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 42364 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 316280 0
University
Name [1] 316280 0
The University of Melbourne
Country [1] 316280 0
Australia
Funding source category [2] 317656 0
Commercial sector/Industry
Name [2] 317656 0
Orthosport Victoria Institute
Country [2] 317656 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 319970 0
Commercial sector/Industry
Name [1] 319970 0
Orthosport Victoria Institute
Address [1] 319970 0
Country [1] 319970 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315099 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 315099 0
Ethics committee country [1] 315099 0
Australia
Date submitted for ethics approval [1] 315099 0
01/10/2024
Approval date [1] 315099 0
Ethics approval number [1] 315099 0

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

Contacts
Principal investigator
Name 133674 0
Dr Scott Starkey
Address 133674 0
Movement Laboratory, 202 Berkeley Street Parkville, The University of Melbourne, Victoria 3010
Country 133674 0
Australia
Phone 133674 0
+61 0439702870
Fax 133674 0
Email 133674 0
[email protected]
Contact person for public queries
Name 133675 0
Scott Starkey
Address 133675 0
Movement Laboratory, 202 Berkeley Street Parkville, The University of Melbourne, Victoria 3010
Country 133675 0
Australia
Phone 133675 0
+61 0439702870
Fax 133675 0
Email 133675 0
[email protected]
Contact person for scientific queries
Name 133676 0
Scott Starkey
Address 133676 0
Movement Laboratory, 202 Berkeley Street Parkville, The University of Melbourne, Victoria 3010
Country 133676 0
Australia
Phone 133676 0
+61 0439702870
Fax 133676 0
Email 133676 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a relatively small feasibility/hypothesis generating study. Also, Uni of Melbourne ethics guidelines prevent us from making participant data publicly available.


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.