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Trial registered on ANZCTR


Registration number
ACTRN12620001344987
Ethics application status
Approved
Date submitted
10/11/2020
Date registered
14/12/2020
Date last updated
14/12/2020
Date data sharing statement initially provided
14/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Mallet and Extension Relative Motion Splinting Trial
Scientific title
A randomised controlled trial evaluating the effect of adjunctive extension relative motion splints on extensor lag for patients with tendinous closed mallet finger injuries.
Secondary ID [1] 302703 0
nil known
Universal Trial Number (UTN)
U1111-1260-7936
Trial acronym
MERMS Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mallet finger 319617 0
Condition category
Condition code
Musculoskeletal 317561 317561 0 0
Other muscular and skeletal disorders
Injuries and Accidents 317958 317958 0 0
Fractures
Injuries and Accidents 317959 317959 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Extension relative motion splinting of metacarpophalangeal joint of injured finger (additional to standard care control arm)
Why: To relax the extensor mechanism of the injured finger, allowing the ruptured terminal tendon ends to heal without tension - in theory this should reduce residual extensor lag at the distal interphalangeal joint
What: Orficast extension relative motion splint (ERMS - see attached splinting protocol)
Who Provided: Senior hand therapists (as per attached splinting protocol)
How: In person
Where: In a city hospital outpatient setting (2 centres)
When and How Much: For 8 weeks continuously (plus additional 2 weeks continuously if an extension lag is present after 8 weeks splinting). Splint is only removed for approximately 5 minutes twice per day to perform hygiene and finger abduction exercises. These exercises will entail fully spreading the fingers and bringing them back together again for 20 repetitions.
Tailoring: ERMS is custom made to fit each patient
How Well (Planned): Assessment of compliance by hand therapist using standardised method (Groth GN, Wilder DM, Leroy Young V: The Impact of Compliance on the Rehabilitation of Patients with Mallet Finger Injuries. Journal of Hand Therapy 7:21-24, 1994)
Intervention code [1] 318986 0
Treatment: Devices
Comparator / control treatment
Brief Name: Static extension splinting of distal interphalangeal joint (DIPJ) of injured finger
Why: To bring the ruptured terminal extensor tendon ends together to heal
What: Orficast static circumferential DIPJ splint (see attached splinting protocol)
Who Provided: Senior hand therapists (as per attached splinting protocol)
How: In person
Where: In a city hospital outpatient setting (2 centres)
When and How Much: For 8 weeks continuously (plus additional 2 weeks continuously if an extension lag is present after 8 weeks splinting).
Tailoring: splint is custom made to fit each patient
How Well (Planned): Assessment of compliance by hand therapist using standardised method (Groth GN, Wilder DM, Leroy Young V: The Impact of Compliance on the Rehabilitation of Patients with Mallet Finger Injuries. Journal of Hand Therapy 7:21-24, 1994)
Control group
Active

Outcomes
Primary outcome [1] 325607 0
Extensor lag at distal interphalangeal joint (degrees), assessed using goniometer
Timepoint [1] 325607 0
2 weeks post cessation of full time splinting (primary timepoint), 22 weeks post study enrolment
Secondary outcome [1] 388527 0
Patient satisfaction with each splint as assessed using custom 5-point Likert scale
Timepoint [1] 388527 0
at cessation of full time splinting
Secondary outcome [2] 388528 0
Active range of motion at distal interphalangeal joint (degrees), assessed using goniometer
Timepoint [2] 388528 0
2 weeks post cessation of full time splinting, 22 weeks post study enrolment
Secondary outcome [3] 388530 0
Change in active range of motion at proximal interphalangeal joint (degrees), assessed using goniometer
Timepoint [3] 388530 0
2 weeks post cessation of full time splinting, 22 weeks post study enrolment
Secondary outcome [4] 388532 0
total active range of motion of injured finger (degrees), assessed using goniometer
Timepoint [4] 388532 0
2 weeks post cessation of full time splinting, 22 weeks post study enrolment
Secondary outcome [5] 388534 0
any complications eg skin ulceration (only known complication) - patient diary will be used and skin integrity will be checked by hand therapist as part of standard care at each visit
Timepoint [5] 388534 0
22 weeks post study enrolment
Secondary outcome [6] 388536 0
Patient rated outcome measure of hand function using the 'Patient Rated Hand and Wrist Evaluation' tool (MacDermid JC: The PRWE/PRWHE update. Journal of Hand Therapy 32:292-294, 2019)
Timepoint [6] 388536 0
2 weeks post cessation of full time splinting, 22 weeks post study enrolment

Eligibility
Key inclusion criteria
• Closed bony or soft tissue mallet injury of a finger without joint subluxation
• Suitable for mallet splint
• Suitable for relative motion splint
• Extensor lag at presentation greater than 10 degrees (measured by goniometer)
• Injury less than or equal to 14 days old
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patient not able to consent themselves
• Previous or current injuries/disease affecting same 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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation (random block sizes of 4 and 6) with stratification for presence of a fracture
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)
Safety/efficacy
Statistical methods / analysis
A sample of 64 patients (32 in each arm) will achieve more than 80% power to detect an absolute reduction in mean extensor lag of 3.6 degrees in DIPJ extension splint + ERMS (intervention arm). The mean extensor lag in patients treated with DIPJ extension splint alone (standard care) is assumed to be 7.6 degrees with a standard deviation of 4.5. The power calculation was based on a two-sided two-sample equal-variance t-test with a significance level of 5% (alpha). The sample size was adjusted with a 10% non-compliance rate.
All analyses will be conducted on an intention-to-treat basis. All randomised patients will be
analysed in the group to which they were assigned regardless of protocol violations, unless they withdraw within the first seven days post randomisation in which case they will be excluded, and the trial slot reallocated with a new randomisation code. The only other exception will be patients whose consent to use their data in the analysis is withheld or withdrawn. All tests will be two-sided with a nominal level of alpha of 5%. Baseline characteristics for each treatment group will be compared. The primary outcome, extensor lag at 2 weeks post cessation of full-time splinting, will be summarised as mean (standard deviation (SD)) for each arm. The primary efficacy of DIPJ extension splint + ERMS over DIPJ extension splint alone will be assessed and tested using one-way analysis of
covariance (ANCOVA) and group differences evaluated using ANCOVA. Secondary categorical outcomes will be described by their frequency (proportion) in each arm and compared using a Pearson chi-squared test. In cases where the expected count per cell is less than five, Fisher’s exact test will be used. Overall treatment effect of categorical outcomes will be summarised using the odds ratio and its 95% confidence interval (CI). A sensitivity analysis using a per protocol approach will also be conducted.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17988 0
Westmead Hospital - Westmead
Recruitment hospital [2] 17989 0
Auburn Hospital & Community Health Services - Auburn
Recruitment postcode(s) [1] 31946 0
2145 - Westmead
Recruitment postcode(s) [2] 31947 0
2144 - Auburn

Funding & Sponsors
Funding source category [1] 307137 0
Government body
Name [1] 307137 0
Western Sydney Local Health District
Address [1] 307137 0
Westmead Hospital, Darcy Rd, Westmead NSW 2145
Country [1] 307137 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Westmead Hospital, Darcy Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 307772 0
None
Name [1] 307772 0
Address [1] 307772 0
Country [1] 307772 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307249 0
Western Sydney Local Health District HREC
Ethics committee address [1] 307249 0
Research Office, Level 2, REN Building
Westmead Hospital, Hawkesbury & Darcy Roads, Westmead NSW 2145
Ethics committee country [1] 307249 0
Australia
Date submitted for ethics approval [1] 307249 0
25/08/2020
Approval date [1] 307249 0
28/09/2020
Ethics approval number [1] 307249 0
2020/ETH01810

Summary
Brief summary
The primary purpose of this study is to improve the healing of an injury to the extensor tendon of the finger known as ‘mallet finger’ by improved splinting. The disorder is caused by disruption of the extensor tendon to the most distal bone of the finger, resulting in an inability to fully straighten the finger.

The current standard care for mallet finger injuries uses a splint that statically immobilises the most distal finger joint (DIPJ) in extension. However, in many patients the tendon heals slightly long, ending up with them losing the ability to fully extend their finger, known as a lag. Therefore, we propose using an additional splint that attaches to the adjacent (uninjured) fingers just beyond the knuckles and lifts the injured finger up slightly, known as an extension relative motion splint (ERMS). This results in the injured finger adopting a slightly flexed posture that relaxes the extensor tendon. We hypothesise that this will result in improved healing of the extensor tendon and therefore a reduced risk of lag. Importantly, the uninjured joints can still be fully straightened whilst wearing the ERMS, to prevent them becoming contracted in one position.

This project will randomise around 60 patients to have either one (standard) or two (standard and ERMS) moulded plastic splints. The patients will also be stratified according to whether or not they have a small associated fracture. Splinting will be for eight weeks, with an additional two weeks if there is a lag noted after 8 weeks.

The primary outcome will be extensor lag measured at two weeks after ceasing full time splinting. Secondary outcomes will be patient satisfaction, active range of motion (AROM) at the DIPJ, change in AROM at the proximal finger joint, total AROM of the finger, and complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106562 0
Dr Alexander Varey
Address 106562 0
Department of Plastic Surgery
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead
NSW 2145
Country 106562 0
Australia
Phone 106562 0
+61288905555
Fax 106562 0
Email 106562 0
Alex.Varey@health.nsw.gov.au
Contact person for public queries
Name 106563 0
Dr Alexander Varey
Address 106563 0
Department of Plastic Surgery
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead
NSW 2145
Country 106563 0
Australia
Phone 106563 0
+61288905555
Fax 106563 0
Email 106563 0
Alex.Varey@health.nsw.gov.au
Contact person for scientific queries
Name 106564 0
Dr Alexander Varey
Address 106564 0
Department of Plastic Surgery
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead
NSW 2145
Country 106564 0
Australia
Phone 106564 0
+61288905555
Fax 106564 0
Email 106564 0
Alex.Varey@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
What supporting documents are/will be available?
Other
'Other' documents specified
Splinting protocol
Study schedule
How or where can supporting documents be obtained?
Type [1] 9695 0
Other
Citation [1] 9695 0
Link [1] 9695 0
Email [1] 9695 0
Other [1] 9695 0
Splinting protocol
Type [2] 9696 0
Other
Citation [2] 9696 0
Link [2] 9696 0
Email [2] 9696 0
Other [2] 9696 0
Study schedule for patients
Type [3] 10019 0
Other
Citation [3] 10019 0
Link [3] 10019 0
Email [3] 10019 0
Other [3] 10019 0
Patient diary
Summary results
No Results