NCT00310570

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

April 4, 2006

Status Verified

April 1, 2006

First QC Date

April 2, 2006

Last Update Submit

April 2, 2006

Conditions

Keywords

distalinterphalangealextensor tendonavulsion

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

Age16 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

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: 11560435BACKGROUND
  • Handoll HH, Vaghela MV. Interventions for treating mallet finger injuries. Cochrane Database Syst Rev. 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.

MeSH Terms

Conditions

Fractures, Avulsion

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Lisa O'Brien, M.Clin.Sci

    The Alfred

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Bloom, MBBS, FRACS

CONTACT

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

Locations