Comparison of Splinting Interventions for Treating Mallet Finger Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00310570
Recruitment Status : Unknown
Verified April 2006 by Bayside Health.
Recruitment status was:  Not yet recruiting
First Posted : April 4, 2006
Last Update Posted : April 4, 2006
Information provided by:
Bayside Health

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.

Condition or disease Intervention/treatment Phase
Mallet Finger Device: Circumferential thermoplastic thimble splint Device: dorsal aluminium foam "Mexican Hat" splint Device: stack splint (control) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Comparison of Splinting Interventions for Minimising Extensor Lag in Mallet Finger Injuries
Study Start Date : May 2006
Study Completion Date : September 2007

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

Secondary Outcome Measures :
  1. Active range of motion at DIP
  2. Patient compliance with splinting regime, based on self-report (as described above)
  3. Patient satisfaction with result on 5-point likert scale
  4. Complications
  5. Pain, measured by 10 point Visual Analogue Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00310570

Contact: Richard Bloom, MBBS, FRACS +613 9276 2000

Australia, Victoria
The Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Lisa O'Brien, M.Clin.Sci    +61 9276 3526   
Contact: Ben Cunningham, B.Occ.Ther    +61 9276 3526   
Principal Investigator: Lisa O'Brien, M.Clin.Sci         
Sub-Investigator: Ben Cunningham, B.Occ Ther         
Sponsors and Collaborators
Bayside Health
Principal Investigator: Lisa O'Brien, M.Clin.Sci The Alfred

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00310570     History of Changes
Other Study ID Numbers: Project 58/06
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: April 4, 2006
Last Verified: April 2006

Keywords provided by Bayside Health:
extensor tendon

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