Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000758404p
Ethics application status
Submitted, not yet approved
Date submitted
26/06/2025
Date registered
17/07/2025
Date last updated
17/07/2025
Date data sharing statement initially provided
17/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised comparative trial of patients following surgical repair of finger flexor tendons, comparing the effect of two splints, on patient-reported hand function and quality of life and clinician-reported range of motion and grip strength.
Scientific title
A randomised comparative trial of patients following surgical repair of finger flexor tendons, comparing the effect of a Manchester short splint versus a forearm-based dorsal blocking splint, on patient-reported hand function and quality of life and clinician-reported range of motion and grip strength.
Secondary ID [1] 314714 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Finger flexor tendon injury 337910 0
Condition category
Condition code
Physical Medicine / Rehabilitation 334238 334238 0 0
Physiotherapy
Injuries and Accidents 334237 334237 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is the Manchester short splint. This is a splint that extends from the back of the wrist crease to the fingertips. As per usual clinical practice, this splint will be custom-made by a hand therapist (physiotherapist or occupational therapist) and applied within the first 5 days post-operatively, with instructions to wear the splint full time for the first 6 weeks post-operatively (this may be shortened to approximately 5 weeks if indicated due to severe adhesions/stiffness and/or difficulty regaining range of motion, as per usual clinical practice). The position of joints within the splint will, as per usual clinical practice, be customised for the zone of repair and the position modified if required by individual factors such as associated nerve repair/tension. Participant feedback about adherence to splint wear will be recorded.
Intervention code [1] 331320 0
Treatment: Other
Intervention code [2] 331403 0
Treatment: Devices
Intervention code [3] 331321 0
Rehabilitation
Comparator / control treatment
Participants will be allocated to receive either a forearm-based dorsal blocking splint or a Manchester short splint.
Control group
Active

Outcomes
Primary outcome [1] 341903 0
Patient-reported symptoms, function, aesthetics and satisfaction with hand function. This will be assessed as a composite outcome.
Timepoint [1] 341903 0
Baseline, 3 months post-injury, 6 months post-injury. Primary time point is 3 months post-injury.
Secondary outcome [1] 448926 0
Finger range of motion
Timepoint [1] 448926 0
Three months post-injury, six months post-injury
Secondary outcome [2] 448927 0
Grip strength
Timepoint [2] 448927 0
Three months post-injury, six months post-injury
Secondary outcome [3] 448928 0
Level of adherence with management
Timepoint [3] 448928 0
Three months post-injury, six months post-injury
Secondary outcome [4] 448924 0
Health-related quality of life
Timepoint [4] 448924 0
Baseline, 3 months post-injury, 6 months post-injury
Secondary outcome [5] 448925 0
Return to work and leisure activities. This will be assessed as a composite outcome.
Timepoint [5] 448925 0
Three months post-injury, six months post-injury

Eligibility
Key inclusion criteria
Admitted to the Royal Adelaide Hospital with traumatic, finger flexor tendon injury who undergo surgical repair. Tendon injuries can include those to zones 1-5, to one or multiple flexor tendons, to one or multiple digits, with only other minor structures damaged (e.g., pulley, digital nerve).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refuse consent. Other major injuries (e.g., fracture, major nerve injury [as associated with poorer outcomes]). Unable to understand written/spoken English. Major psychiatric/psychological problems. Self-inflicted injury. Unable to commit to returning for follow-up out-patient appointments. Patients who sustain the injury at work and are subsequently on Work Cover (as hand therapy occurs in private setting).

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)
Allocation will be concealed. Group allocation will be revealed by contacting one of the investigators who is offsite.
schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation table has been created.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation for this study was undertaken based on the primary outcome, namely, the total score for the Michigan Hand Questionnaire (at 3 months post-injury). Based on a standard deviation of 21.4 and assuming standard deviation will be the same in the two groups, a sample size of 33 per group will be required to detect a mean difference between groups of 15, with a difference of 15 considered clinically important. Thus, a sample size of 66 participants will be sought.

Data will be imported into SPSS for basic descriptive analyses. Comparison of outcomes will be undertaken with the help of a statistician using linear mixed-effects models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
1/08/2027
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 28134 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 44340 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 319267 0
Hospital
Name [1] 319267 0
CALHN Allied and Scientific Health Research Grant
Country [1] 319267 0
Australia
Funding source category [2] 319270 0
Self funded/Unfunded
Name [2] 319270 0
In kind support from staff involved and any consumables required for the study (e.g. splinting material)
Country [2] 319270 0
Australia
Primary sponsor type
Individual
Name
Nicola Williams, Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 321740 0
Individual
Name [1] 321740 0
Kathy Stiller, Central Adelaide Local Health Network
Address [1] 321740 0
Country [1] 321740 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317845 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 317845 0
Ethics committee country [1] 317845 0
Australia
Date submitted for ethics approval [1] 317845 0
29/05/2025
Approval date [1] 317845 0
Ethics approval number [1] 317845 0

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

Contacts
Principal investigator
Name 142334 0
Ms Nicola Williams
Address 142334 0
Outpatients and Speciality Services, Royal Adelaide Hospital, Port Road, Adelaide, South Australia 5000
Country 142334 0
Australia
Phone 142334 0
+61 870744000
Fax 142334 0
Email 142334 0
[email protected]
Contact person for public queries
Name 142335 0
Nicola Williams
Address 142335 0
Outpatients and Speciality Services, Royal Adelaide Hospital, Port Road, Adelaide, South Australia 5000
Country 142335 0
Australia
Phone 142335 0
+61 870744000
Fax 142335 0
Email 142335 0
[email protected]
Contact person for scientific queries
Name 142336 0
Nicola Williams
Address 142336 0
Outpatients and Speciality Services, Royal Adelaide Hospital, Port Road, Adelaide, South Australia 5000
Country 142336 0
Australia
Phone 142336 0
+61 870744000
Fax 142336 0
Email 142336 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.