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Trial registered on ANZCTR
Registration number
ACTRN12622001425785p
Ethics application status
Submitted, not yet approved
Date submitted
30/10/2022
Date registered
8/11/2022
Date last updated
8/11/2022
Date data sharing statement initially provided
8/11/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparing two different interventions for treatment of volar plate injuries.
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Scientific title
A randomised clinical trial comparing outcomes of a single digit volar plate injury. Buddy loops versus dorsal thermoplastic orthosis (Eaton Type I, II, IIIA)
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Secondary ID [1]
306683
0
None
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Universal Trial Number (UTN)
U1111-1275-6909
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Volar plate injury
325817
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Condition category
Condition code
Musculoskeletal
323143
323143
0
0
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Other muscular and skeletal disorders
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Injuries and Accidents
325188
325188
0
0
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Fractures
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Group 1 will receive their initial treatment within in 14 days of sustaining their injury and will be treated in a dorsal blocking orthosis in a neutral position, full-time and commence Active Range of Motion (AROM) within the orthosis. This will involve isolated distal interphalangeal joint flexion/extension exercises, proximal interphalangeal joint flexion/extension exercises and composite flexion/extension exercises and will be asked to be completed 10 repetitions, 6 times per day. Patients will be shown how to complete these exercises at their initial treatment session and will be asked to complete them at home and will be reviewed and assessed at the treatment sessions by the treating hand therapist. The initial treatment session is anticipated to take approximately 45 minutes for treatment and 30 mins for assessment.
The orthosis will be weaned if clinically appropriate at week 3 (post intervention), where by the patient will need to continue to wear it for sleeping and 'at risk' situations/activities. If clinically appropriate the orthosis will be discharged at week 5 (post intervention).
Patient will be asked how often they are completing their exercises at each assessment point and a questionnaire will be completed at the 3 week assessment (3 post intervention) to assess adherence to treatment, including splinting. Subsequent treatment sessions are anticipated to take approximately 30 minutes for treatment and 30 minutes for assessment.
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Intervention code [1]
323231
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Treatment: Devices
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Comparator / control treatment
Group 2 will receive their initial treatment within 14 days of sustaining their injury and will be treated with buddy loops The injured digit will be buddied to an uninjured border digit and, full-time and will commence AROM exercises within the buddy loops. This will involve composite flexion/extension exercises and will be asked to be completed 10 repetitions, 6times per day. Patients will be shown how to complete these exercises at their initial treatment session and will be asked to complete them at home and will be reviewed and assessed at the treatment sessions by the treating hand therapist. The initial treatment session is anticipated to take approximately 45 minutes for treatment and 30 mins for assessment.
The buddy loops will be weaned if clinically appropriate at week 3 (post intervention), where by the patient will need to continue to wear it for sleeping and 'at risk' situations/activities. If clinically appropriate the buddy loops will be discharged at week 5 (post intervention).
Patient will be asked how often they are completing their exercises at each assessment point and a questionnaire will be completed at the 3 week assessment (3 post intervention) to assess adherence to treatment, including buddy loops. Subsequent treatment sessions are anticipated to take approximately 30 minutes for treatment and 30 minutes for assessment.
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Control group
Active
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Outcomes
Primary outcome [1]
330899
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Passive Proximal Interphalangeal Joint (PIPJ) extension
This will be assessed using a finger goniometer.
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Assessment method [1]
330899
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Timepoint [1]
330899
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Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Primary timepoint - Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [1]
407979
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Active Metacarpal Phalangeal Joint (MCPJ) Range Of Motion (ROM)
This will be assessed using a finger goniometer.
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Assessment method [1]
407979
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Timepoint [1]
407979
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Initial (pre-intervention - within 14 days of injury)
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [2]
407980
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Active Proximal Interphalangeal Joint (PIPJ) Range of Motion (ROM)
This will be assessed using a finger goniometer.
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Assessment method [2]
407980
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Timepoint [2]
407980
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Initial (pre-intervention - within 14 days of injury)
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [3]
407981
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Active Distal Interphalangeal Join (DIPJ) Range of Motion (ROM)
This will be assessed using a finger goniometer.
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Assessment method [3]
407981
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Timepoint [3]
407981
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Initial (pre-intervention - within 14 days of injury))
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [4]
407982
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Total Active Motion (TAM)
This will be assessed using a finger goniometer.
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Assessment method [4]
407982
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Timepoint [4]
407982
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Initial (pre-intervention - within 14 days of injury))
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [5]
407983
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Passive Metacarpal Phalangeal Joint (MCPJ) Range Of Motion (ROM)
This will be assessed using a finger goniometer.
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Assessment method [5]
407983
0
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Timepoint [5]
407983
0
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [6]
407984
0
Passive Proximal Interphalangeal Joint (PIPJ) Range of Motion (ROM)
This will be assessed using a finger goniometer.
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Assessment method [6]
407984
0
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Timepoint [6]
407984
0
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [7]
407985
0
Passive Distal Interphalangeal Join (DIPJ) Range of Motion (ROM)
This will be assessed using a finger goniometer.
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Assessment method [7]
407985
0
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Timepoint [7]
407985
0
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [8]
407986
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Total Passive Motion (TPM)
This will be assessed using a finger goniometer.
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Assessment method [8]
407986
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Timepoint [8]
407986
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Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [9]
407987
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Function - Patient Rated Wrist and Hand Evaluation (PRWHE)
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Assessment method [9]
407987
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Timepoint [9]
407987
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Initial (pre-intervention - within 14 days of injury)
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [10]
407988
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Pain - Numeric Rating Scale
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Assessment method [10]
407988
0
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Timepoint [10]
407988
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Initial (pre-intervention - within 14 days of injury)
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [11]
407989
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Oedema - Circumferential measurement of the PIPJ
This will be assessed with a tape measure.
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Assessment method [11]
407989
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Timepoint [11]
407989
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Initial (pre-intervention - within 14 days of injury)
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [12]
407990
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Return to Work/Usual everyday activities
This will be assessed as a composite outcome using a questionnaire that has been utilised for research within the Sydney Hospital Hand Unit but if not validated.
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Assessment method [12]
407990
0
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Timepoint [12]
407990
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Initial (pre-intervention - within 14 days of injury)
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [13]
407991
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Grip Strength - Jamar Dynamometer
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Assessment method [13]
407991
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Timepoint [13]
407991
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Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Secondary outcome [14]
407992
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Adherence to treatment
This will be assessed using a questionnaire. The questionnaire was based on the work of Sandord et al (2008) but is not validated.
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Assessment method [14]
407992
0
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Timepoint [14]
407992
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Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
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Secondary outcome [15]
415554
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Pain - pain section of the Patient Rated Wrist and Hand Evaluation (PRWHE)
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Assessment method [15]
415554
0
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Timepoint [15]
415554
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Initial (pre-intervention - within 14 days of injury)
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
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Eligibility
Key inclusion criteria
Closed volar plate injury (Eaton type I, II or IIIa)
Initial treatment within 14 days of injury
Does not require surgery
Adequate cognitive functioning
Can give informed consent
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Concomitant tendon, nerve vascular or bony injury
Open injury
Previous injury/condition affecting range of motion in the same or contralateral digit
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Descriptive statistics.
Independent samples t-tests will be used review the statistical significance of these differences in means at follow-up.
Analysis of covariance (ANCOVA) will be used to adjust for any differences between groups at baseline.
Data will be analysed using an ‘intention to treat’ analysis.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
21/11/2022
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Actual
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Date of last participant enrolment
Anticipated
20/05/2024
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Actual
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Date of last data collection
Anticipated
15/07/2024
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Actual
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Sample size
Target
64
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
22048
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Sydney Hospital and Sydney Eye Hospital - Sydney
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Recruitment postcode(s) [1]
37170
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2000 - Sydney
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Funding & Sponsors
Funding source category [1]
311014
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Hospital
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Name [1]
311014
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Sydney Hospital and Sydney Eye Hospital
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Address [1]
311014
0
8 Macquarie Street, Sydney, NSW 2000
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Country [1]
311014
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Australia
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Primary sponsor type
Hospital
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Name
Sydney Hospital and Sydney Eye Hospital
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Address
8 Macquarie Street, Sydney, NSW 2000
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Country
Australia
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Secondary sponsor category [1]
312326
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University
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Name [1]
312326
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Western Sydney University
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Address [1]
312326
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Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
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Country [1]
312326
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
310562
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South Eastern Sydney Local Health District - Human Research Ethics Committee
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Ethics committee address [1]
310562
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1 Reserve Road St Leonards NSW 2065 Australia
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Ethics committee country [1]
310562
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Australia
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Date submitted for ethics approval [1]
310562
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17/06/2022
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Approval date [1]
310562
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Ethics approval number [1]
310562
0
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Summary
Brief summary
This study plans to determine if splinting in a neutral (straight) position of more effective than buddy loops in preventing reduced extension (straightening) at the proximal interphalangeal joint (middle joint of the finger). Specific hypotheses will address; splinting the PIPJ in a neutral position produces a) a lower average extension contracture of FFD than splinting in buddy loops; b) lower mean pain scores than buddy loops; c) lower mean oedema measure than buddy loops; and d) splinting the PIPJ in a neutral position results in changed Participants will be randomly assigned to one group and both will commence active exercises within the splint or buddy loop. Both interventions will be worn full-time for 3 weeks and then discharged at 5 weeks. Each participant will be treated and assessed by experienced hand therapists (occupational therapists or physiotherapists) and the assessing therapist will be blinded to the treatment group of there participants. Assessment will be undertaken at their initial presentation, weeks' 3, 5 and 8.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Sarah Walsh
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Address
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Sydney Hospital Hand Unit
Level 2 - Clinical Services Building
8 Macquarie Street
Sydney, NSW
2000
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Country
118094
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Australia
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Phone
118094
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+61 2 93827206
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Fax
118094
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Email
118094
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[email protected]
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Contact person for public queries
Name
118095
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Sarah Walsh
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Address
118095
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Sydney Hospital Hand Unit
Level 2 - Clinical Services Building
8 Macquarie Street
Sydney, NSW
2000
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Country
118095
0
Australia
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Phone
118095
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+61 2 93827206
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Fax
118095
0
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Email
118095
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[email protected]
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Contact person for scientific queries
Name
118096
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Sarah Walsh
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Address
118096
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Sydney Hospital Hand Unit
Level 2 - Clinical Services Building
8 Macquarie Street
Sydney, NSW
2000
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Country
118096
0
Australia
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Phone
118096
0
+61 2 93827206
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Fax
118096
0
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Email
118096
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Stats will be reported as a whole
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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
Source
Title
Year of Publication
DOI
Embase
A randomised clinical trial comparing outcomes of a single digit volar plate injury - Buddy loops versus dorsal thermoplastic orthosis in a neutral position: study protocol.
2023
https://dx.doi.org/10.1186/s12891-023-06192-5
N.B. These documents automatically identified may not have been verified by the study sponsor.
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