Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001027606
Ethics application status
Approved
Date submitted
18/08/2023
Date registered
22/09/2023
Date last updated
22/09/2023
Date data sharing statement initially provided
22/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An elastic knee brace for patients with ongoing symptoms following anterior cruciate ligament reconstruction: a pilot study
Scientific title
Effects of wearing an elastic knee brace for six weeks in young adults at risk of knee osteoarthritis after anterior cruciate ligament (ACL) reconstruction: a pilot study
Secondary ID [1] 310051 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12623001008617 will investigate the immediate effects of the knee brace while this study is a follow-up to investigate the longer term effects.

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament reconstruction 330583 0
Post-traumatic osteoarthritis 330584 0
Condition category
Condition code
Physical Medicine / Rehabilitation 327419 327419 0 0
Physiotherapy
Musculoskeletal 327420 327420 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Genutrain Elastic Knee Brace (Bauerfeind® AG, Zeulenroda-Triebes, Germany), a Therapeutic Goods Administration (TGA) approved medical device. The brace will be sized and fitted appropriately as per manufacturer’s instructions.

Participants randomised to the brace group will receive the brace to wear daily during weight-bearing activities (e.g., walking, running, sports) for 6 weeks. Participants will also receive an educational handout detailing the potential benefit of wearing the elastic knee brace, appropriate brace use and care instructions, and standard product information provided by the manufacturer. No specific restrictions will be applied to other aspects of usual care. Hours each day of brace use will be recorded via paper-based or electronic logbooks (participant preference).
Intervention code [1] 326458 0
Treatment: Devices
Comparator / control treatment
No treatment.

Participants randomised to the control group will not receive the elastic knee brace or any educational handout at baseline. After completing the 6-week follow-up assessment, participants will receive the same elastic knee brace. No specific restrictions will be applied to other aspects of usual care.
Control group
Active

Outcomes
Primary outcome [1] 335286 0
Feasibility of conducting a full-scale RCT will be assessed by a composite of:
- Integrity of protocol (participant acceptability, completeness of outcomes – determined via semi-structured interviews and audit of study outcomes)
- Recruitment and retention (recruitment rate, eligibility rate, enrolment rate, drop-out rate – determine by an audit of study screening, enrolment and withdrawal logs)
- Adherence of brace use assessed by log books, including subjective rating of adherence (0 = never wore brace to 10 = always wore brace when doing weight-bearing activities)
- Occurrence of adverse events, such as pain flares, skin reactions/irritation determined by log books
- Patient satisfaction with treatment (0 = not at all to 10 = extremely satisfied)

Semi-structured interviews exploring acceptability, satisfaction and factors associated with adherence will be conducted and audio-recorded at week 6 follow-up by a member of the research team (approx. 30mins).
Timepoint [1] 335286 0
Recruitment and retention will be assessed upon conclusion of the study.
Integrity of the protocol, adherence of brace use, occurrence of adverse events and patient satisfaction with treatment will be assessed 6 weeks post-baseline.
Secondary outcome [1] 423740 0
KOOS4; The average score of 4 of the 5 Knee injury and Osteoarthritis Outcome Score (KOOS) subscales covering pain, symptoms, difficulty in sports and recreational activities and quality of life
Timepoint [1] 423740 0
Change from baseline to 6 weeks
Secondary outcome [2] 423741 0
Fear of movement: Tampa Scale for Kinesiophobia
Timepoint [2] 423741 0
Change from baseline to 6 weeks
Secondary outcome [3] 423742 0
Knee demanding physical activity: Tegner Activity Scale
Timepoint [3] 423742 0
Change from baseline to 6 weeks
Secondary outcome [4] 423743 0
Knee-related Quality of Life: ACL-QoL Questionnaire
Timepoint [4] 423743 0
Change from baseline to 6 weeks
Secondary outcome [5] 423747 0
General physical activity: International Physical Activity Questionnaire (IPAQ)
Timepoint [5] 423747 0
Change from baseline to 6 weeks
Secondary outcome [6] 423748 0
Participant perception of achievement of acceptable symptoms: Patient acceptable symptom state (PASS)
Timepoint [6] 423748 0
6 weeks post-baseline
Secondary outcome [7] 423750 0
KOOS-pain
Timepoint [7] 423750 0
Change from baseline to 6 weeks
Secondary outcome [8] 423751 0
KOOS-symptoms
Timepoint [8] 423751 0
Change from baseline to 6 weeks
Secondary outcome [9] 423752 0
KOOS-activities of daily living
Timepoint [9] 423752 0
Change from baseline to 6 weeks
Secondary outcome [10] 423753 0
KOOS-Sport and Recreation
Timepoint [10] 423753 0
Change from baseline to 6 weeks
Secondary outcome [11] 423754 0
KOOS-Quality of life
Timepoint [11] 423754 0
Change from baseline to 6 weeks
Secondary outcome [12] 423756 0
Lower-limb functional performance assessed with the hop for distance test
Timepoint [12] 423756 0
Change from baseline to 6 weeks
Secondary outcome [13] 423760 0
Vertical hop test assessing maximum hop height
Timepoint [13] 423760 0
Change from baseline to 6 weeks
Secondary outcome [14] 423761 0
Biomechanics of walking using 3D VICON system (infrared cameras tracking reflective markers)
Timepoint [14] 423761 0
Change from baseline to 6 weeks
Secondary outcome [15] 423762 0
Biomechanics of hopping using 3D VICON system (infrared cameras tracking reflective markers)
Timepoint [15] 423762 0
Change from baseline to 6 weeks
Secondary outcome [16] 426707 0
Global rating of change (GROC) for function on a seven point Likert scale (from much worse to much better).
Timepoint [16] 426707 0
6 weeks post baseline
Secondary outcome [17] 426708 0
Global rating of change (GROC) for pain on a seven point Likert scale (from much worse to much better).
Timepoint [17] 426708 0
6 weeks post-baseline

Eligibility
Key inclusion criteria
(i) ACL reconstruction surgery 1-8 years ago; (ii) Aged 18-45 years; (iii)A symptomatic ACLR knee (defined as KOOS4 score <80/100); (iv) Willing to wear an elastic knee brace during weight-bearing activities for 6 weeks
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Knee injury/surgery or knee injection in the past 3 months; (ii) Participation in physiotherapy treatment for either knee in the past month; (iii) Routinely wearing a knee brace in the last 3 months (iv) Other injury or health condition affecting the ability to complete functional tasks (e.g. hopping); (v) Existence of any of the following in the ACL reconstructed leg: skin disorders or allergies, swollen/hot/red scars, varicose veins, neurological abnormalities, impaired blood flow or lymphatic drainage, undiagnosed soft tissue swelling; (vi) Currently pregnant; (vii) Unable to commit to the various study assessments over the 6 weeks; (viii) Unable to understand written and/or spoken English

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)
Participants will be randomised to either the knee brace intervention or control (no brace) group. The randomisation schedule will be generated by a secure randomisation service established independently to the research team (concealed allocation). The randomisation schedule for each participant will be maintained centrally by La Trobe University (REDCap) and revealed to an unblinded member of the research team who will communicate group allocation to the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
2:1 randomisation ratio (computerised sequence generation), with more participants randomised to the brace group to allow a larger sample to provide feasibility data on brace use.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Primary outcome of feasibility will be assessed using integrity of the protocol, recruitment and retention rate, adherence with the intervention, adverse events, and patient satisfaction. These will be analysed descriptively in combination with feedback from post-study interviews. Quantitative data (changes in patient-reported, functional, biomechanical data between baseline and follow-up) will be compared for the 6-week effects between brace vs no brace groups, using appropriate statistical tests depending on statistical assumptions being met.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314217 0
Government body
Name [1] 314217 0
National Health and Medical Research Council
Country [1] 314217 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia
Country
Australia
Secondary sponsor category [1] 316150 0
None
Name [1] 316150 0
Address [1] 316150 0
Country [1] 316150 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313341 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 313341 0
Kingsbury Drive, Bundoora, Victoria 3086
Ethics committee country [1] 313341 0
Australia
Date submitted for ethics approval [1] 313341 0
23/06/2023
Approval date [1] 313341 0
04/09/2023
Ethics approval number [1] 313341 0
HEC23249

Summary
Brief summary
The primary aim of this pilot study is to determine the feasibility of wearing an elastic knee brace (Genutrain, Bauerfeind) for 6 weeks on clinical and biomechanical features of early knee osteoarthritis after ACL reconstruction. Together with a pilot cross-over study to estimate the immediate-effects of the brace (separate trial registration), this pilot study will inform a future full-scale RCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127802 0
Dr Adam Culvenor
Address 127802 0
Health Science 3, La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia
Country 127802 0
Australia
Phone 127802 0
+61 3 9479 5116
Fax 127802 0
Email 127802 0
a.culvenor@latrobe.edu.au
Contact person for public queries
Name 127803 0
Dr Adam Culvenor
Address 127803 0
Health Science 3, La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia
Country 127803 0
Australia
Phone 127803 0
+61 3 9479 5116
Fax 127803 0
Email 127803 0
a.culvenor@latrobe.edu.au
Contact person for scientific queries
Name 127804 0
Dr Adam Culvenor
Address 127804 0
Health Science 3, La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia
Country 127804 0
Australia
Phone 127804 0
+61 3 9479 5116
Fax 127804 0
Email 127804 0
a.culvenor@latrobe.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
We have not planned to share individual participant data at this stage.


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.