Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000123549
Ethics application status
Approved
Date submitted
27/03/2006
Date registered
5/04/2006
Date last updated
22/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of splinting interventions in treating mallet finger injuries
Scientific title
Comparison of splinting interventions for preventing extensor lag in mallet finger injuries
Secondary ID [1] 281574 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mallet finger 1088 0
Condition category
Condition code
Musculoskeletal 1169 1169 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be allocated to one of the following groups using a randomised computer sequence:
- Circumferential thermoplastic thimble splint, or
- Dorsally applied aluminium-foam “Mexican hat” splint
In all cases, splinting will be applied for a minimum of 6 weeks continuously, with weaning of splint after this depending on recovery.
Intervention code [1] 956 0
Treatment: Other
Comparator / control treatment
Subjects will receive:
- Control splint (pre-fabricated stack splint with tape).
In all cases, splinting will be applied for a minimum of 6 weeks continuously, with weaning of splint after this depending on recovery.
Control group
Active

Outcomes
Primary outcome [1] 1573 0
Degree of extensor lag in injured finger
Timepoint [1] 1573 0
At 10, 12 and 20 weeks post commencement of splinting
Secondary outcome [1] 2849 0
Active joint movement
Timepoint [1] 2849 0
Measured at 10, 12 and 20 weeks
Secondary outcome [2] 2850 0
Patient compliance with splint regime
Timepoint [2] 2850 0
Measured at 10, 12 and 20 weeks
Secondary outcome [3] 2851 0
Patient satisfaction
Timepoint [3] 2851 0
Measured at 10, 12 and 20 weeks
Secondary outcome [4] 2852 0
Complications
Timepoint [4] 2852 0
Measured at 10, 12 and 20 weeks

Eligibility
Key inclusion criteria
Mallet finger injuries will be considered for inclusion.
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Open injuriesmallet injury to thumbco-existing rheumatological illnesstime from injury to presentation greater than 2 weeks.

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)
patient and therapist will be unaware of the next treatment (or control) group to be assigned at the time of recruitment to the trial. Allocation will be concealed by using sealed opaque envelopes with the treatment type unknown to the therapist and unable to be changed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomised sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1277 0
Hospital
Name [1] 1277 0
The Alfred Hospital Allied Health Research Grant
Country [1] 1277 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
Commercial Rd
Melbourne 3004
Country
Australia
Secondary sponsor category [1] 1131 0
None
Name [1] 1131 0
n/a
Address [1] 1131 0
Country [1] 1131 0
Other collaborator category [1] 277197 0
Hospital
Name [1] 277197 0
Southern Health
Address [1] 277197 0
Dandenong Hospital,
David Street Dandenong
Country [1] 277197 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2608 0
The Alfred Research and Ethics Unit
Ethics committee address [1] 2608 0
Ethics committee country [1] 2608 0
Australia
Date submitted for ethics approval [1] 2608 0
Approval date [1] 2608 0
Ethics approval number [1] 2608 0
Ethics committee name [2] 288443 0
Southern Health HREC B
Ethics committee address [2] 288443 0
246 Clayton Rd
Clayton 3168
Ethics committee country [2] 288443 0
Australia
Date submitted for ethics approval [2] 288443 0
Approval date [2] 288443 0
31/07/2009
Ethics approval number [2] 288443 0
09110B

Summary
Brief summary
Stubbing of the finger-tip is a common injury in sports such as basketball, volleyball, cricket and football. This can result in a Mallet finger deformity, where the end joint of a finger cannot be actively straightened out. In most mallet finger cases seen at The Alfred, the skin remains intact, and the impairment results from a tear of the extensor tendon or an avulsion (a small fracture where the tendon attaches to the bone). Treatment commonly involves immobilising the end joint of the finger in a splint for six or more weeks so patient compliance is a major factor in the quality of the outcome achieved.

This study aims to compare two different types of splintage (the commonly used thermoplastic thimble splint and the aluminium-foam “Mexican hat” splint which is in use in Britain) with a control splint (thermoplastic prefabricated “stack splint” with tape). Outcome measures will include patient compliance with the splint, degree of extensor lag, active movement of the joint, and any complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35266 0
Address 35266 0
Country 35266 0
Phone 35266 0
Fax 35266 0
Email 35266 0
Contact person for public queries
Name 10145 0
Mr Richard Bloom, Plastic Surgeon
Address 10145 0
The Alfred Hospital
PO Box 315
Prahran VIC 3181
Country 10145 0
Australia
Phone 10145 0
+61 3 92762000
Fax 10145 0
+61 3 92762255
Email 10145 0
[email protected]
Contact person for scientific queries
Name 1073 0
Lisa O'Brien
Address 1073 0
Occupational Therapy Department
The Alfred Hospital
PO Box 315
Prahran VIC 3181
Country 1073 0
Australia
Phone 1073 0
+61 3 92763526
Fax 1073 0
+61 3 92762920
Email 1073 0
[email protected]

No information has been provided regarding IPD availability


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
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