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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00310570
Registration number
NCT00310570
Ethics application status
Date submitted
2/04/2006
Date registered
4/04/2006
Date last updated
4/04/2006
Titles & IDs
Public title
Comparison of Splinting Interventions for Treating Mallet Finger Injuries
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Scientific title
Comparison of Splinting Interventions for Minimising Extensor Lag in Mallet Finger Injuries
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Secondary ID [1]
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Project 58/06
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mallet Finger
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Circumferential thermoplastic thimble splint
Treatment: Devices - dorsal aluminium foam "Mexican Hat" splint
Treatment: Devices - stack splint (control)
Treatment: Devices: Circumferential thermoplastic thimble splint
Treatment: Devices: dorsal aluminium foam "Mexican Hat" splint
Treatment: Devices: stack splint (control)
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Degree of extensor lag at distal inter-phalangeal (DIP)joint
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Active range of motion at DIP
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Patient compliance with splinting regime, based on self-report (as described above)
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Patient satisfaction with result on 5-point likert scale
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Complications
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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Pain, measured by 10 point Visual Analogue Scale
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Assessment method [5]
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Timepoint [5]
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Eligibility
Key inclusion criteria
- All referrals of patients with mallet finger injuries will be considered for inclusion
with the exception of the following exclusion criteria.
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Minimum age
16
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- open injuries
- mallet injury to thumb
- co-existing rheumatologic illness
- time from injury to presentation greater than 2 weeks
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Ethics approval
Ethics application status
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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.
The null hypothesis is that there are no differences in outcome between different methods of
conservative splinting treatment for mallet finger.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00310570
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Trial related presentations / publications
Wilson SW, Khoo CT. The Mexican hat splint--a new splint for the treatment of closed mallet finger. J Hand Surg Br. 2001 Oct;26(5):488-9. doi: 10.1054/jhsb.2001.0590.
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Public notes
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Contacts
Principal investigator
Name
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Lisa O'Brien, M.Clin.Sci
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Address
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The Alfred
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Richard Bloom, MBBS, FRACS
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Address
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Country
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Phone
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+613 9276 2000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00310570
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