Comparison of Splinting Interventions for Treating Mallet Finger Injuries

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Bayside Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00310570
First received: April 2, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Mallet Finger
Device: Circumferential thermoplastic thimble splint
Device: dorsal aluminium foam "Mexican Hat" splint
Device: stack splint (control)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Comparison of Splinting Interventions for Minimising Extensor Lag in Mallet Finger Injuries

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Degree of extensor lag at distal inter-phalangeal (DIP)joint

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: May 2006
Estimated Study Completion Date: September 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- All referrals of patients with mallet finger injuries will be considered for inclusion with the exception of the following exclusion criteria.

Exclusion Criteria:

  • open injuries
  • mallet injury to thumb
  • co-existing rheumatologic illness
  • time from injury to presentation greater than 2 weeks
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00310570

Contacts
Contact: Richard Bloom, MBBS, FRACS +613 9276 2000 R.Bloom@alfred.org.au

Locations
Australia, Victoria
The Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Lisa O'Brien, M.Clin.Sci    +61 9276 3526    L.Obrien@alfred.org.au   
Contact: Ben Cunningham, B.Occ.Ther    +61 9276 3526    B.Cunningham@alfred.org.au   
Principal Investigator: Lisa O'Brien, M.Clin.Sci         
Sub-Investigator: Ben Cunningham, B.Occ Ther         
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Lisa O'Brien, M.Clin.Sci The Alfred Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00310570     History of Changes
Other Study ID Numbers: Project 58/06
Study First Received: April 2, 2006
Last Updated: April 2, 2006
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:
distal
interphalangeal
extensor tendon
avulsion

Additional relevant MeSH terms:
Finger Injuries
Wounds and Injuries
Hand Injuries

ClinicalTrials.gov processed this record on August 26, 2014