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Trial registered on ANZCTR


Registration number
ACTRN12619000449134
Ethics application status
Approved
Date submitted
25/02/2019
Date registered
19/03/2019
Date last updated
10/11/2021
Date data sharing statement initially provided
19/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Managing volar plate finger injuries with two different splints
Scientific title
Managing stable Proximal Interphalangel Joint (PIPJ) volar plate injuries with figure 8 splinting
Secondary ID [1] 296982 0
None
Universal Trial Number (UTN)
U1111-1226-3106
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Volar plate injury 310947 0
Condition category
Condition code
Musculoskeletal 309613 309613 0 0
Other muscular and skeletal disorders
Injuries and Accidents 310374 310374 0 0
Fractures
Injuries and Accidents 310375 310375 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised controlled trial will compare two treatment methods for management of stable volar plate injuries to the proximal interphalangeal joint of the finger. The aim is to determine if management with figure 8 splinting with an exercise plan provides similar or improved results to the current treatment used in the hand clinic of dorsal block
splinting with an exercise plan. The only variation in treatment between the two groups will be the splint participants are provided.
The figure 8 splint is less restrictive and allows more functional use of the hand with the splint on. Each splint is made out of thermoplastic (orfit, 1.6mm thickness) and is fabricated specifically for each patient.
Participants will be randomly assigned to one of the two treatment groups and will follow the designated treatment protocol for those groups. Each participant will be assessed by either an occupational therapist or physiotherapist experienced in the management of volar plate injuries. Each treating clinician will assess, fabricate splints, complete measurement and provide the exercise plans. All of these procedures will be completed during a face to face treatment session. Measurement will be quantitative, using goniometry (measuring finger range of movement), visual analogue scale (VAS) to measure pain severity, circumferential
oedema measurement, and the Disabilities of the Arm, Shoulder and Hand scale. Measurement will occur at the time of initial assessment, and at approximately 4 and 12 weeks after commencement of treatment.
The home exercise plan consists of active and passive movements of the metacarpal phalangeal, proximal interphalangeal and distal interphalangeal joints which are completed 5 times a day (10 repititions of active hooks and fists, 5 repititions of 20 second stretches into flexion).
Intervention code [1] 313257 0
Treatment: Devices
Comparator / control treatment
dorsal blocking splinting serially adjusted weekly for 4 weeks (1st week 30 degrees of flexion, 2nd week 20 degrees flexion, 3rd week 10 degrees of flexion, 4th week 0 degrees of flexion).
All other treatment and assessment is consistent with the other treatment group
Control group
Active

Outcomes
Primary outcome [1] 318573 0
changes in flexion range of movement (measured in degrees) at the proximal and distal interphalangeal joints
- measured using a finger goniometer
Timepoint [1] 318573 0
weeks 1 (initial assessment),4 post initial assessment, 7 post initial assessment, 12 post initial assessment
Primary outcome [2] 318574 0
number of outpatient appointments attended - review of appointments attended through review in medical file
Timepoint [2] 318574 0
12 weeks post initial assessment assessment
Primary outcome [3] 318575 0
changes in hand function as measured by the quick DASH (disabilities of arm, shoulder and hand) outcome measure
Timepoint [3] 318575 0
weeks 1 (initial assessment),4 post initial assessment, 7 post initial assessment, 12 post initial assessment
Secondary outcome [1] 365403 0
changes in oedema
- measured using a tape measure in millimeters
Timepoint [1] 365403 0
weeks 1 (initial assessment),4 post initial assessment, 7 post initial assessment, 12 post initial assessment
Secondary outcome [2] 365404 0
changes in pain severity (as measured by the visual analogue scale)
Timepoint [2] 365404 0
weeks 1 (initial assessment),4 post initial assessment, 7 post initial assessment, 12 post initial assessment
Secondary outcome [3] 368331 0
changes in extension range of movement (measured in degrees) at the proximal and distal interphalangeal joints
- measured using a finger goniometer
Timepoint [3] 368331 0
4 post initial assessment, 7 post initial assessment, 12 post initial assessment

Eligibility
Key inclusion criteria
volar plate injury to one proximal interphalangeal joint of the 2nd-5th digits
stable injury as defined by eaton classification
injury less than two weeks old
Minimum age
13 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If potential participants have had less than 3 previous injuries with near full recovery (as stated by individual) they would be included. Exception to this is if they have had surgery on injured digit.
Previous injury to injured digit was also changed via the ethics committee.
Multiple injured digits
English as second language
Significant cognitive impairment
Individuals highly dependent on care

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)
central randomisation by computer
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 receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/11/2018
Date of last participant enrolment
Anticipated
15/11/2019
Actual
28/05/2021
Date of last data collection
Anticipated
17/02/2020
Actual
22/07/2021
Sample size
Target
60
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12827 0
Bendigo Health Care Group - Anne Caudle campus - Bendigo
Recruitment hospital [2] 12828 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment postcode(s) [1] 25297 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 301554 0
Hospital
Name [1] 301554 0
Bendigo Health
Country [1] 301554 0
Australia
Primary sponsor type
Hospital
Name
Bendigo Health
Address
100 Barnard Street Bendigo VIC 3550
Country
Australia
Secondary sponsor category [1] 301251 0
None
Name [1] 301251 0
n/a
Address [1] 301251 0
n/a
Country [1] 301251 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302287 0
Bendigo Health Care Group Human Research Ethics Committee
Ethics committee address [1] 302287 0
Ethics committee country [1] 302287 0
Australia
Date submitted for ethics approval [1] 302287 0
03/09/2018
Approval date [1] 302287 0
01/11/2018
Ethics approval number [1] 302287 0
HREC/18/BHCG/29

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

Contacts
Principal investigator
Name 89702 0
Mr Matthew Grange
Address 89702 0
Bendigo Health
Outpatient Rehabilitation Services
PO Box 126 Bendigo VIC 3552
Country 89702 0
Australia
Phone 89702 0
+61 3 5454 9112
Fax 89702 0
Email 89702 0
mgrange@bendigohealth.org.au
Contact person for public queries
Name 89703 0
Matthew Grange
Address 89703 0
Bendigo Health
Outpatient Rehabilitation Services
PO Box 126 Bendigo VIC 3552
Country 89703 0
Australia
Phone 89703 0
+61 3 5454 9112
Fax 89703 0
Email 89703 0
mgrange@bendigohealth.org.au
Contact person for scientific queries
Name 89704 0
Matthew Grange
Address 89704 0
Bendigo Health
Outpatient Rehabilitation Services
PO Box 126 Bendigo VIC 3552
Country 89704 0
Australia
Phone 89704 0
+61 3 5454 9112
Fax 89704 0
Email 89704 0
mgrange@bendigohealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data not required, 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
No additional documents have been identified.