NCT00310570|Unknown
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Sponsor study identifier
interventional
100
1 country
1
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2006
Actual (reported)April 4, 2006
Actual (reported)May 2006
Date type not reportedThis date has not been verified as actual or estimated.
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Degree of extensor lag at distal inter-phalangeal (DIP)joint
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
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
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.
Handoll HH, Vaghela MV. Interventions for treating mallet finger injuries. Cochrane Database Syst Rev. 2004;2004(3):CD004574. doi: 10.1002/14651858.CD004574.pub2.
O'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.
Lisa O'Brien, M.Clin.Sci
The Alfred
First Submitted
April 2, 2006
First Posted
April 4, 2006
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
September 2007
Date type not reportedClinical Trial Comparing Volar, Dorsal, and Custom Thermoplastic Splinting in the Treatment of Acute Mallet Finger
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This date has not been verified as actual or estimated.
Last Updated
April 4, 2006
Record last verified: 2006-04
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Source: ClinicalTrials.gov.
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