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Trial registered on ANZCTR


Registration number
ACTRN12616001313426
Ethics application status
Approved
Date submitted
6/09/2016
Date registered
19/09/2016
Date last updated
8/04/2021
Date data sharing statement initially provided
9/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of two splint treatment protocols of tendinous mallet finger Injuries
Scientific title
Efficacy of two splint treatment protocols for tendinous mallet finger injuries.
Secondary ID [1] 289967 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tendinous Mallet finger injuries 299966 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299858 299858 0 0
Occupational therapy
Injuries and Accidents 300134 300134 0 0
Other injuries and accidents
Musculoskeletal 300135 300135 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Current literature supports the conservative management over surgical management for type one tendinous mallet injuries (ie full or partial rupture of the terminal insertion of the extensor tendon in the finger). However the gold standard of conservative treatment
is still under development and a topic for debate amongst researchers and clinicians.
This study will include two groups: the 'Standard Care Group' will follow the 'standard' tendinous mallet splint protocol of a custom-made thermoplastic splint including and blocking the DIP joint in extension/hyperextension with the PIP joint free for eight weeks full time wear followed by four weeks of intermittent day wear and nocturnal wear. The 'Standard Care Group' data will be collected retrospectively.
The 'PIP protocol group', will wear a custom-made thermoplastic splint which blocks the PIP joint in a controlled flexion range for the initial two-four weeks (determined by the natural laxity of the volar plate and hyperextension of the PIP joint) together with the DIP joint blocked in extension/hyperextension, before continuing with the 'standard' protocol for up to eight weeks of continuous splint wear followed by a further four weeks of protective and nocturnal wear. It is proposed that the 'PIP Protocol Group' data will be followed prospectively. All subjects will be asked at each treatment intervention regarding their adherence to the treatment protocol, and any diversions or changes noted.
Proposed methodology:
Quantitative methods will be used to compare the outcomes for the two treatment groups. Approximately 30 people will be recruited retrospectively to analyse outcomes of the standard treatment group. Approximately 30 people will be recruited prospectively for the PIP protocol group.
Patients with a Zone One tendinous mallet finger injury, who fit the selection criteria and agree to participation in the study, will be allocated to a group – 'Standard care' or 'PIP protocol' care.
In the initial phase all patients will be treated using the 'Standard care' group. This phase will continue for a period of three months or until a total of 30 patients is reached and will include retrospective clients who provide consent to access their records.
Following completion of this phase, all subsequent patients will be allocated to the 'PIP protocol' group for a period of three months or until a total of 30 patients is reached for this group.

The Occupational Therapy staff at Specialised Hand Therapy Service will conduct the standard treatment trial at any of their nine practice locations in Western Australia, with Dr Janet Richmond from ECU School of Medical and Health Sciences taking the chief investigator role. Data analysis will be conducted using SPSS. Correlations of outcomes
will be investigated. Standard deviation and t-test statistics will be calculated to determine effect size and significance of the treatment protocol.
Intervention code [1] 295656 0
Treatment: Devices
Intervention code [2] 295657 0
Rehabilitation
Intervention code [3] 295658 0
Prevention
Comparator / control treatment
The 'Standard care group' (control group) will follow the 'standard' tendinous mallet splint
protocol of a splint including the DIP joint in extension/hyperextension with the PIP joint free for eight weeks full time wear followed by four weeks of intermittent day wear and nocturnal wear.
Control group
Active

Outcomes
Primary outcome [1] 299335 0
DIP joint extensor lag, assessed using a finger goniometer
Timepoint [1] 299335 0
At Initial appointment prior to treatment and at 8 weeks, 10 weeks and at Discharge (12+ weeks) post commencement of treatment.
Primary outcome [2] 299616 0
PIP joint hyperextension range, assessed using a finger goniometer
Timepoint [2] 299616 0
At Initial appointment prior to treatment and at 8 weeks, 10 weeks and at Discharge (12+ weeks) post commencement of treatment.
Primary outcome [3] 299617 0
Total active range of motion of the DIP joint, assessed using a finger goniometer and calculated by subtracting the achievable extension range of the DIP joint from the achievable flexion range of the DIP joints,
Timepoint [3] 299617 0
At Initial appointment prior to treatment and at 8 weeks, 10 weeks and at Discharge (12+ weeks) post commencement of treatment.
Secondary outcome [1] 326865 0
Satisfaction with treatment outcome, assessed using Satisfaction VAS
Timepoint [1] 326865 0
Assessed at Discharge (12+ weeks) post commencement of treatment.
Secondary outcome [2] 327693 0
Grip strength comparison injured to non-injured hand, assessed using Jamar Dynamometer
Timepoint [2] 327693 0
Assessed at Discharge (12+ weeks) post commencement of treatment.

Eligibility
Key inclusion criteria
Inclusion criteria: Only people fitting the following criteria will be recruited:
> only people aged 18 to 65 years
>Zone One extensor tendon tendinous mallet injuries of the fingers
>less than three weeks post injury at the time of the initial assessment
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
>bony avulsion fracture mallet injuries
>aged below 18 or older than 65 years
>Previous mallet injury at the same joint
> Previous injury to the same finger that may impact outcomes e.g. Swan Neck deformity, fixed flexion
deformity, pre-existing reduced range of motion.
> laceration or open tendon mallet injuries
> surgical repairs
>a patient who experienced the injury more than three weeks prior to the initial presentation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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 analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2016
Actual
17/02/2016
Date of last participant enrolment
Anticipated
1/06/2019
Actual
11/10/2019
Date of last data collection
Anticipated
11/04/2020
Actual
20/03/2020
Sample size
Target
60
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294340 0
Other
Name [1] 294340 0
Specialised Hand Therapy Services
Country [1] 294340 0
Australia
Primary sponsor type
Other
Name
Specialised Hand Therapy Services
Address
17 Colin St
West Perth WA 6005
Country
Australia
Secondary sponsor category [1] 293179 0
None
Name [1] 293179 0
Address [1] 293179 0
Country [1] 293179 0
Other collaborator category [1] 279167 0
University
Name [1] 279167 0
Edith Cowan University
Address [1] 279167 0
Dr Janet Richmond
School of Medical and Health Sciences
270 Joondalup Drive
Joondalup wa 6027
Country [1] 279167 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295758 0
Human Research Ethics Committee
Ethics committee address [1] 295758 0
Ethics committee country [1] 295758 0
Australia
Date submitted for ethics approval [1] 295758 0
10/11/2015
Approval date [1] 295758 0
17/02/2016
Ethics approval number [1] 295758 0
Project code 13869 RICHMOND

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

Contacts
Principal investigator
Name 68370 0
Dr Janet Richmond
Address 68370 0
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 68370 0
Australia
Phone 68370 0
+61 8 6304 3575
Fax 68370 0
Email 68370 0
j.richmond@ecu.edu.au
Contact person for public queries
Name 68371 0
Cathy Thomas
Address 68371 0
Specialised Hand Therapy Services
17 Colin St
West Perth WA 6005
Country 68371 0
Australia
Phone 68371 0
+61 8 9324 2881
Fax 68371 0
Email 68371 0
reception@spht.com.au
Contact person for scientific queries
Name 68372 0
Cathy Thomas
Address 68372 0
Specialised Hand Therapy Services
17 Colin St
West Perth WA 6005
Country 68372 0
Australia
Phone 68372 0
+61 8 9324 2881
Fax 68372 0
Email 68372 0
cathy.thomas@spht.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing of data was not covered in our ethics information and consent form. In addition, we are not bound by any funding body to share the IPD with other researchers. If a particular participant requests their own information, that can be shared with them via the therapist conducting the treatment


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.