Comparison of Splinting Interventions for Treating Mallet Finger Injuries
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2006
CompletedFirst Posted
Study publicly available on registry
April 4, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedApril 4, 2006
April 1, 2006
April 2, 2006
April 2, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Degree of extensor lag at distal inter-phalangeal (DIP)joint
Secondary Outcomes (5)
Active range of motion at DIP
Patient compliance with splinting regime, based on self-report (as described above)
Patient satisfaction with result on 5-point likert scale
Complications
Pain, measured by 10 point Visual Analogue Scale
Interventions
Eligibility Criteria
You may not qualify if:
- open injuries
- mallet injury to thumb
- co-existing rheumatologic illness
- time from injury to presentation greater than 2 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayside Healthlead
Study Sites (1)
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Related Publications (3)
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.
PMID: 11560435BACKGROUNDHandoll HH, Vaghela MV. Interventions for treating mallet finger injuries. Cochrane Database Syst Rev. 2004;(3):CD004574. doi: 10.1002/14651858.CD004574.pub2.
PMID: 15266538RESULTO'Brien LJ, Bailey MJ. Single blind, prospective, randomized controlled trial comparing dorsal aluminum and custom thermoplastic splints to stack splint for acute mallet finger. Arch Phys Med Rehabil. 2011 Feb;92(2):191-8. doi: 10.1016/j.apmr.2010.10.035.
PMID: 21272714DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa O'Brien, M.Clin.Sci
The Alfred
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
April 2, 2006
First Posted
April 4, 2006
Study Start
May 1, 2006
Study Completion
September 1, 2007
Last Updated
April 4, 2006
Record last verified: 2006-04