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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.
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)
Secondary ID [1] 306683 0
None
Universal Trial Number (UTN)
U1111-1275-6909
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Volar plate injury 325817 0
Condition category
Condition code
Musculoskeletal 323143 323143 0 0
Other muscular and skeletal disorders
Injuries and Accidents 325188 325188 0 0
Fractures

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 323231 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 330899 0
Passive Proximal Interphalangeal Joint (PIPJ) extension

This will be assessed using a finger goniometer.
Timepoint [1] 330899 0
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)
Secondary outcome [1] 407979 0
Active Metacarpal Phalangeal Joint (MCPJ) Range Of Motion (ROM)

This will be assessed using a finger goniometer.
Timepoint [1] 407979 0
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)
Secondary outcome [2] 407980 0
Active Proximal Interphalangeal Joint (PIPJ) Range of Motion (ROM)

This will be assessed using a finger goniometer.
Timepoint [2] 407980 0
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)
Secondary outcome [3] 407981 0
Active Distal Interphalangeal Join (DIPJ) Range of Motion (ROM)

This will be assessed using a finger goniometer.
Timepoint [3] 407981 0
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)
Secondary outcome [4] 407982 0
Total Active Motion (TAM)

This will be assessed using a finger goniometer.
Timepoint [4] 407982 0
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)
Secondary outcome [5] 407983 0
Passive Metacarpal Phalangeal Joint (MCPJ) Range Of Motion (ROM)

This will be assessed using a finger goniometer.
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)
Secondary outcome [6] 407984 0
Passive Proximal Interphalangeal Joint (PIPJ) Range of Motion (ROM)

This will be assessed using a finger goniometer.
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)
Secondary outcome [7] 407985 0
Passive Distal Interphalangeal Join (DIPJ) Range of Motion (ROM)

This will be assessed using a finger goniometer.
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)
Secondary outcome [8] 407986 0
Total Passive Motion (TPM)

This will be assessed using a finger goniometer.
Timepoint [8] 407986 0
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
Secondary outcome [9] 407987 0
Function - Patient Rated Wrist and Hand Evaluation (PRWHE)
Timepoint [9] 407987 0
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)
Secondary outcome [10] 407988 0
Pain - Numeric Rating Scale
Timepoint [10] 407988 0
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)
Secondary outcome [11] 407989 0
Oedema - Circumferential measurement of the PIPJ

This will be assessed with a tape measure.
Timepoint [11] 407989 0
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)
Secondary outcome [12] 407990 0
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.
Timepoint [12] 407990 0
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)
Secondary outcome [13] 407991 0
Grip Strength - Jamar Dynamometer
Timepoint [13] 407991 0
Week 5 (Post Intervention) - (orthosis/buddy loops - discharge)
Week 8 (Post Intervention) - ( end of treatment)
Secondary outcome [14] 407992 0
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.
Timepoint [14] 407992 0
Week 3 (Post Intervention) - (orthosis/buddy loops - wean)
Secondary outcome [15] 415554 0
Pain - pain section of the Patient Rated Wrist and Hand Evaluation (PRWHE)
Timepoint [15] 415554 0
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)

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/11/2022
Actual
Date of last participant enrolment
Anticipated
20/05/2024
Actual
Date of last data collection
Anticipated
15/07/2024
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22048 0
Sydney Hospital and Sydney Eye Hospital - Sydney
Recruitment postcode(s) [1] 37170 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 311014 0
Hospital
Name [1] 311014 0
Sydney Hospital and Sydney Eye Hospital
Country [1] 311014 0
Australia
Primary sponsor type
Hospital
Name
Sydney Hospital and Sydney Eye Hospital
Address
8 Macquarie Street, Sydney, NSW 2000
Country
Australia
Secondary sponsor category [1] 312326 0
University
Name [1] 312326 0
Western Sydney University
Address [1] 312326 0
Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
Country [1] 312326 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310562 0
South Eastern Sydney Local Health District - Human Research Ethics Committee
Ethics committee address [1] 310562 0
Ethics committee country [1] 310562 0
Australia
Date submitted for ethics approval [1] 310562 0
17/06/2022
Approval date [1] 310562 0
Ethics approval number [1] 310562 0

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

Contacts
Principal investigator
Name 118094 0
Ms Sarah Walsh
Address 118094 0
Sydney Hospital Hand Unit
Level 2 - Clinical Services Building
8 Macquarie Street
Sydney, NSW
2000
Country 118094 0
Australia
Phone 118094 0
+61 2 93827206
Fax 118094 0
Email 118094 0
sarah.walsh1@health.nsw.gov.au
Contact person for public queries
Name 118095 0
Sarah Walsh
Address 118095 0
Sydney Hospital Hand Unit
Level 2 - Clinical Services Building
8 Macquarie Street
Sydney, NSW
2000
Country 118095 0
Australia
Phone 118095 0
+61 2 93827206
Fax 118095 0
Email 118095 0
sarah.walsh1@health.nsw.gov.au
Contact person for scientific queries
Name 118096 0
Sarah Walsh
Address 118096 0
Sydney Hospital Hand Unit
Level 2 - Clinical Services Building
8 Macquarie Street
Sydney, NSW
2000
Country 118096 0
Australia
Phone 118096 0
+61 2 93827206
Fax 118096 0
Email 118096 0
sarah.walsh1@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Stats will be reported as a whole


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
SourceTitleYear of PublicationDOI
EmbaseA randomised clinical trial comparing outcomes of a single digit volar plate injury - Buddy loops versus dorsal thermoplastic orthosis in a neutral position: study protocol.2023https://dx.doi.org/10.1186/s12891-023-06192-5
N.B. These documents automatically identified may not have been verified by the study sponsor.