Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001714178
Ethics application status
Approved
Date submitted
19/11/2019
Date registered
5/12/2019
Date last updated
13/04/2022
Date data sharing statement initially provided
5/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Advances in Hand Therapy: Best practice in conservative management of proximal phalangeal fractures in children.
Scientific title
Advances in Hand Therapy: Reducing splinting time in conservative management of proximal phalangeal fractures in children that have been been assessed as being clinically healed.
Secondary ID [1] 299792 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Finger fracture
 315168 0
Condition category
Condition code
Injuries and Accidents 313556 313556 0 0
Fractures
Physical Medicine / Rehabilitation 313748 313748 0 0
Other physical medicine / rehabilitation
Musculoskeletal 313749 313749 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Splinting (group 1) vs no splinting (group 2) of proximal phalangeal fractures that have been clinically assessed as being healed at 3 weeks post injury.
All face to face interventions will be delivered at The Children's Hospital at Westmead outpatient department.

Visit 1, 30 minutes (within 2 weeks post fracture) - Study information will be provided to potential participants.
- Fabrication of a thermoplastic splint and instructions given about full-time wearing regime and precautions.
Visit 2, 30 minutes (range 3 weeks to 4 weeks post immobilisation) - Administration staff to obtain consent.
- Eligibility for stage 2 inclusion will be assessed by a senior hand therapist
- For those eligible envelope randomization will be used to determine study group
- All participants will have total active motion (TAM) measures recorded of their affected digit/s and the contralateral digit/s on the unaffected hand. TAM will be measured using a rolyan goniometer.
- Participants randomly allocated to Group 1 standard treatment will commence AROM exercises three times per day. Those with finger injuries will commence tendon gliding exercises x 10 repetitions and finger lifts x 10 repetitions. Those with thumb injuries will commence thumb finger touch x 10 repetitions and slides x 10 repetitions. Participants will be instructed to remove their splints for exercises and light functional use at home only. Splints must be worn overnight, for school and for high risk activities.
- Participants allocated to the Group 2 new protocol group will commence the same exercises as those who receive standard treatment, as outlined above. Participants will be instructed to cease splinting from this appointment. They are able to resume light activities and will be advised not to participate in sports or high risk activities. Therapists will advise the participant to buddy tape the affected finger to the adjacent finger if there is concern about the participant’s ability to follow safety instructions.
- Participants will then be booked in with a different senior hand therapist/investigator for their 5 week follow up appointment which will ensure blinding of therapists.
Visit 3, 30 minutes (5 weeks to 6 weeks post immobilisation)
- Participants will attend their scheduled appointment and check in with reception staff. For participants in group 1 who are wearing splints reception staff will ask them to take their splint off to ensure investigators are blinded to their group allocation.
- Participants will have TAM measures recorded of their affected digit/s and the contralateral digit/s on the unaffected hand. TAM will be measured using a rolyan goniometer.
- Participants will have grip strength measured, and those with thumb fractures will also have lateral pinch strength measured using a citec dynamometer. Participants will be instructed to hold their elbow by their side and at approximately 90 degrees of flexion. The investigator will give verbal instructions and modeling will be used to assist with position. 3 measures will be taken for the unaffected hand and then the affected hand and an average for each hand will be calculated and recorded.
- The patient rated questionnaire PRQ will be administered during the session with questions being asked verbally by the therapist and yes/no responses being recorded.
- Average grip strength, TAM measures and PRQ scores will be entered into an excel spreadsheet.
- The therapist can then be unblinded and review EMR notes if required.
- Commence light strengthening for all participants in both group
- Parents/guardians will be given a choice for follow-up contact at 8 weeks post injury – either email, text or phone call.
Week 8, 5 minutes
- PRQ can be texted, emailed or a phone call will be made. Four attempts will be made to contact participants.
Did not attend appointment - Reception staff will contact and determine why they did not attend. Attempts will be made to book them in ASAP in order to capture all participants at the appropriate time.
Intervention code [1] 316111 0
Rehabilitation
Intervention code [2] 316249 0
Treatment: Other
Comparator / control treatment
Control is Group 1 - continuing splint for a further 2 weeks part-time. Therefore, the splint is worn full-time for the first 3 weeks and then part-time for a further 2 weeks for the control group.

Intervention is Group 2 where they cease wearing the splint after 3 weeks.
Control group
Active

Outcomes
Primary outcome [1] 322013 0
The primary outcome measure is total active motion (TAM), as compared to the contralateral digit. If TAM of the fractured finger at five weeks is no more than 20 degrees less than TAM of the contralateral digit, the range of motion will be defined to be “adequate”. If TAM of the fractured thumb is no more than 15 degrees less than TAM of the contralateral thumb, the range of motion will be defined as ‘adequate’. TAM will be measured at both 3 and 5 weeks for all participants for both the affected digit and unaffected digit on the contralateral side. TAM will be measured using the dorsal method with a short arm Rolyan goniometer, following guidelines from the American Society for Surgery of the Hand, 1990. This method has been considered suitable for these fractures (Kato et el, 2007). Ellis and Bruten in 2002 reported that for finger goniometery intra-rater reliability was within 5 degrees 95% of the time, and 7-9 degrees 95% of the time for inter-rater reliability.
Timepoint [1] 322013 0
TAM is measured at 3 weeks and 5 weeks post commencement intervention (immobilisation)
Secondary outcome [1] 376995 0
The secondary outcome measures are:
• Myometry

Myometry will be measured in both groups at 5 weeks post injury. Myometry of each hand will be assessed for all participants by measuring power grip for fingers and thumb fractures and lateral pinch for thumb fractures using the CITEC dynamometer. This is a reliable method of recording grip strength in children (Molenaar et al, 2008).
Participants will be required to sit with the elbow at 90 degrees and the wrist and forearm in a neutral position. Three measures for power will be taken and participants will be able to rest between each trial and can indicate when they are ready to continue. Grip and pinch strength is compared to the unaffected hand, taking into account hand dominance difference of 10% (Beenakkrel et al, 2001). We will compare grip and pinch strength for the two groups, with one being a control group and the other treatment group.
Timepoint [1] 376995 0
Myometry - 5 weeks post intervention (immobilisation) or 2 weeks post randomisation.
Secondary outcome [2] 376996 0
The PRQ will be completed at 5 weeks within the final session and 8 weeks by phone, text or email. As there are no specific assessments to measure hand function in children following a traumatic hand injury, we will use a series of 5 questions requiring a yes/no answer. These questions will relate to function, pain and re-injury. The PRQ data will be sought from both the participant and the parent/guardian at the 5 week follow-up and the parent/guardian at the 8 week follow-up. To encourage ethical reporting we will encourage parents/guardians to answer questions for the 8 week PRQ after consultation with the participant. Within the 5 week session the therapist will ask the 5 questions verbally and record the answers. The patient and parent will be asked how they would like the PRQ delivered for the 8 week follow-up, with options being either over the phone, text or via email.
Timepoint [2] 376996 0
5 and 8 weeks post commencement of intervention (immobilisation) or 2 weeks and 5 weeks post randomisation.

Eligibility
Key inclusion criteria
INCLUSION CRITERIA
Stage 1:
• Children aged between 5 to 16 years
Confirmed proximal phalanx fracture which is undisplaced or minimally displaced and stable that is being conservatively managed including closed reduction (performed in ED or in outpatient clinic (not in theatre)

• Unaffected contralateral hand
• Early diagnosis (within 2 weeks post fracture)
Stage 2:
• Assessed as being clinically healed at visit 2 by senior hand therapist
Minimum age
5 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
EXCLUSION CRITERIA
• Late presentation (3 weeks post fracture to initial review). Late presentation means the fracture will take longer to heal.
• Behavioral or communication issues which may affect assessment
• Surgical intervention including closed reduction in theatre
• Unable to attend future appointments

• Non- compliance with splinting within the first 3 weeks, as they will not be able to comply with the study protocol.

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)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study is a non-inferiority study with a sample size of 80 participants. In the past six months we have treated approximately 80 patients who fulfil inclusion criteria for the study. None of these patients have needed to be recalled for additional treatment. We are thus confident that the proportion of patients currently achieving adequate TAM is at least 95%. The new intervention would be declared acceptable if the proportion of patients reaching adequate TAM is no more than 20% lower than under current care. The null hypothesis is that the proposed intervention is inferior to current practice, meaning that adequate TAM is achieved in at least 20% more patients on current standard care than on the new intervention. A study of 80 participants (40 per group) has 80% power at 5% one-sided significance to reject this hypothesis if the true rate of adequate TAM under standard care is 95% or higher, using a two-sample chi-square test.
9.2 POWER CALCULATIONS
See calculation above.
9.3 STATISTICAL METHODS TO BE UNDERTAKEN
All analyses will be performed using the intention to treat principle whereby patients are analysed according to their randomised treatment regardless of treatment actually received. Patient and treatment data and study outcomes will be described by randomised treatment and overall using standard descriptive statistics – mean, standard deviation and range or median, interquartile range and range for continuous variables, frequencies and percentages for categorical variables.

The primary outcome of the percentage of patients achieving adequate TAM will be compared between groups using a chi-square test and the absolute difference (current standard care minus new intervention) described by a 90% confidence interval. If the upper confidence limit is 20% or less the new intervention will be declared non-inferior to current standard care.
Other outcomes will be compared between groups i.e. group 1 and group 2, and also between different age groupings (refer to 5.3) using standard statistical tests: two-sample t-tests or non-parametric equivalent for continuous outcomes and chi-square tests for categorical outcomes. Exploratory regression analyses may be used to examine predictors of outcomes.
The sample size is based on the comparison of proportions 75% versus 95%. If the rate of adequate TAM under current care is lower than the assumed 95% then the sample size may be inadequate to establish non-inferiority. Pooled outcome data (combined over treatments) will be assessed by an independent statistician not involved in conduct of the study after approximately half the participants have outcome data available. It is expected that the overall rate of adequate TAM would be 85%. If there is evidence that this assumption is not correct then consideration will be given to modifying the study, for example by increasing the sample size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/08/2018
Date of last participant enrolment
Anticipated
31/05/2021
Actual
17/06/2021
Date of last data collection
Anticipated
12/06/2021
Actual
26/07/2021
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15186 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 28495 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 304257 0
Hospital
Name [1] 304257 0
The Children's Hospital at Westmead
Country [1] 304257 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Corner of Hawkesbury Rd and Hainsworth St, Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 304557 0
None
Name [1] 304557 0
Address [1] 304557 0
Country [1] 304557 0
Other collaborator category [1] 281048 0
University
Name [1] 281048 0
The University of Sydney
Address [1] 281048 0
Cumberland Campus, Lidcombe, NSW, 2141
Country [1] 281048 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304712 0
Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 304712 0
Ethics committee country [1] 304712 0
Australia
Date submitted for ethics approval [1] 304712 0
19/04/2018
Approval date [1] 304712 0
28/06/2018
Ethics approval number [1] 304712 0
HREC/18/SCHN/135

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

Contacts
Principal investigator
Name 97962 0
Ms Rebecca Kilty
Address 97962 0
The Children's Hospital at Westmead
Cnr Hawkesbury and Hainworth St,
Westmead, NSW, 2145
Country 97962 0
Australia
Phone 97962 0
+61 2 9845 3369
Fax 97962 0
+61 2 9845 3685
Email 97962 0
[email protected]
Contact person for public queries
Name 97963 0
Rebecca Kilty
Address 97963 0
The Children's Hospital at Westmead
Cnr Hawkesbury and Hainworth St,
Westmead, NSW, 2145
Country 97963 0
Australia
Phone 97963 0
+61 2 9845 3369
Fax 97963 0
+61 2 9845 3685
Email 97963 0
[email protected]
Contact person for scientific queries
Name 97964 0
Claire Hiller
Address 97964 0
The University of Sydney
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe
NSW, 2141
Country 97964 0
Australia
Phone 97964 0
+61 2 9351 9108
Fax 97964 0
-
Email 97964 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.