Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001010684
Ethics application status
Approved
Date submitted
9/02/2023
Date registered
18/09/2023
Date last updated
18/09/2023
Date data sharing statement initially provided
18/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of longitudinal K-wire immobilisation verses custom thermoplastic orthosis for uncomplicated mallet finger deformity: A randomised controlled trial
Scientific title
Comparison of longitudinal K-wire immobilisation verses custom thermoplastic orthosis for uncomplicated mallet finger deformity: A randomised controlled trial
Secondary ID [1] 308792 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mallet Finger Deformity 328875 0
Condition category
Condition code
Musculoskeletal 325868 325868 0 0
Other muscular and skeletal disorders
Injuries and Accidents 328095 328095 0 0
Other injuries and accidents
Surgery 328096 328096 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Percutaneous Longitudinal K-wire Immobilisation
Longitudinal K-wire immobilisation involves placement of a K-wire from the fingertip, retrograde across the distal interphalangeal joint (DIPJ). The surgery can be completed as a procedure under digital block anaesthesia or under general anaesthesia. The pin will be placed into at least 50% of the length of the medullary canal of the middle phalanx. This mitigates the risk of pin migration. The pin is cut below the skin and the percutaneous incision is closed with a quick-acting skin adhesive. The pin will be removed in theatre at 8 weeks. The surgery is anticipated to take 30-60 minutes. Operative intervention must be performed by consultant surgeons, or by fellows or SET-accredited registrars following discussion of the operative plan with the supervising consultant.
Intervention code [1] 325327 0
Treatment: Surgery
Intervention code [2] 326921 0
Treatment: Devices
Comparator / control treatment
Group 2: Custom Thermoplastic Splint Immobilisation
The distal interphalangeal joint (DIPJ) is immobilised in slight hyperextension for a period of 8 weeks. The patients will be instructed to wear the splint 24 hours per day / 7 days per week. The custom made thermoplastic splint will be made by an accredited hand therapist in the outpatients department following diagnosis of mallet finger deformity and randomisation to group 2. The participant will be reviewed every 1-2 weeks in hand therapy clinic to monitor adherence to the thermoplastic splint and whether the hand therapist assesses the splint needs to be re-made. Our patient satisfaction questionnaire includes a question for group 2 on compliance.
Control group
Active

Outcomes
Primary outcome [1] 333699 0
The primary outcome assessed will be patient satisfaction. This will be assessed at baseline, 8 weeks, 3, 6, and 12-months. The patient satisfaction survey/questionnaire has been specifically designed for this study. It includes both 11-point likert scales Over time, the likert scales will be used to compare the difference in patient reported satisfaction between the interventions.

Currently, there is no validated orthopaedic measure of patient satisfaction.
Timepoint [1] 333699 0
The outcome will be assessed at 8 weeks, 3 months, 6 months, and 12 months following surgery or application of the splint.
Secondary outcome [1] 417987 0
The crawford criteria, which consists of extension lag level, DIP flexion and the visual Analogue Scale (VAS) score to evaluate pain. This examination will be completed by an accredited hand therapist.
Timepoint [1] 417987 0
8 weeks, 3-, 6- and 12-months post-treatment.
Secondary outcome [2] 426268 0
Overall hand function assessed using Michigan Hand Questionnaire (MHQ). This examination will be completed by an accredited hand therapist.
Timepoint [2] 426268 0
8 weeks, 3-, 6- and 12-months post-treatment
Secondary outcome [3] 426269 0
Time out of work assessed using the Disability of Arm, Shoulder and Hand [DASH] questionnaireThis examination will be completed by an accredited hand therapist.
Timepoint [3] 426269 0
8 weeks, 3-, 6- and 12-months post-treatment
Secondary outcome [4] 426270 0
The complications observed/reported for both groups will be recorded. This will include those that are patient-reported and those observed by the research team.
Timepoint [4] 426270 0
These will be recorded throughout the duration of the controlled trial.
Secondary outcome [5] 426271 0
The EQ-5D-5L is a patient reported questionnaire that measure quality of life on a 5-component scale that incorporates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Timepoint [5] 426271 0
8 weeks, 3-, 6- and 12-months post-treatment
Secondary outcome [6] 426272 0
Prospective cost analysis of both interventions. The costs of both interventions will be recorded for later analysis. The operative group will incur more cost initially due to theatre expenses, however, the splint group will require more hand therapy outpatient appointments. The following items are anticipated expenses: consultant/SET surgeon and junior orthopaedic doctors, accredited hand therapist, operating theatre (i.e. hardware, theatre staff, anaesthesia), orthosis-related expenses, outpatient department appoints for hand therapy and orthopaedics, imaging (x-ray), and complication related expenses (i.e. antibiotics for infection). The items incurred by each participant will be recorded to compare the expenses generated by each group.
Timepoint [6] 426272 0
These will be recorded throughout the duration of the controlled trial.
Secondary outcome [7] 426273 0
The global rating of change will also be applied to the participants in the patient satisfaction questionnaire. This will be useful to quantify the patient's perceived improvement or deterioration over time in addition to the primary outcome.
Timepoint [7] 426273 0
8 weeks, 3-, 6- and 12-months post-treatment

Eligibility
Key inclusion criteria
- Patients diagnosed with an uncomplicated closed mallet finger: Soft tissue/tendinous mallet deformity, avulsion fracture of the distal phalanx articular surface that involves less than 1/3 the total articular surface, absence of volar joint subluxation
- Patients assessed on radiographs [confirmed by Consultant Surgeon]
- Aged over 18 years
- Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Associated significant soft tissue injury (including open/tendon damage)
- Pathological fracture
- Presentation >3 weeks
- Unable to comply with the assessment requirements or rehabilitation.
- Fracture best managed by only one of the included intervention options, or another option, as decided by the Consultant Surgeon

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)
Eligible participants will be randomly allocated to the operative or non-operative group via block randomisation. Distance randomization will be performed through an online randomisation service and data storage service - REDcap. After consenting the patient, a member of the research team will enter the patient's details into REDcap, which will then provide the group allocation for the treating clinician to document. Participants will be identified by all orthopaedic doctors but allocation will only be performed by the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As above, this process will be controlled by an online randomisation service and data storage service - REDcap.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
79 patients per arm, 158 patients in total.

Patient satisfaction will be measured using an 11 point likert scale as per the patient satisfaction survey. This will be measured at baseline (pre-treatment), 1 week, 8-weeks, and 3, 6, and 12 months. The primary outcome will be the difference between baseline and 6-months. This sample size power calculation has been determined based on the satisfaction outcomes presented in the study by Aksan et al. who reported approximately 80% satisfaction in the surgical group, compared to 55% satisfaction in the conservative group. The above sample size has accounted for a 10% drop out rate, with an alpha of 0.05 and confidence interval of 90%.

Given there is no validated orthopaedic satisfaction scale, the research team has used the above study as the minimum clinically important difference. We will complete an interim post hoc analysis to confirm the sample size after 50 participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
12/12/2025
Actual
Date of last data collection
Anticipated
12/12/2026
Actual
Sample size
Target
158
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 25483 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 25484 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [3] 25533 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 41295 0
4215 - Southport
Recruitment postcode(s) [2] 41296 0
2077 - Hornsby
Recruitment postcode(s) [3] 41355 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 313008 0
Hospital
Name [1] 313008 0
Gold Coast University Hospital
Country [1] 313008 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Blvd, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 314695 0
None
Name [1] 314695 0
Address [1] 314695 0
Country [1] 314695 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312272 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 312272 0
Ethics committee country [1] 312272 0
Australia
Date submitted for ethics approval [1] 312272 0
02/02/2023
Approval date [1] 312272 0
12/09/2023
Ethics approval number [1] 312272 0

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

Contacts
Principal investigator
Name 124062 0
Prof Randy Bindra
Address 124062 0
Gold Coast University Hospital, Orthopaedic Department, 1 Hospital Blvd, Southport QLD 4215
Country 124062 0
Australia
Phone 124062 0
+61 07 5687 0001
Fax 124062 0
Email 124062 0
[email protected]
Contact person for public queries
Name 124063 0
Max McCarthy
Address 124063 0
Gold Coast University Hospital, 1 Hospital Blvd, Southport QLD 4215
Country 124063 0
Australia
Phone 124063 0
+61 07 5687 0001
Fax 124063 0
Email 124063 0
[email protected]
Contact person for scientific queries
Name 124064 0
Randy Bindra
Address 124064 0
Gold Coast University Hospital, Orthopaedic Department, 1 Hospital Blvd, Southport QLD 4215
Country 124064 0
Australia
Phone 124064 0
+61 07 5687 0001
Fax 124064 0
Email 124064 0
[email protected]

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?

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.