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Completed

NCT Number: NCT01738919

Extension Block Technique Versus Splinting in Mallet Finger Fracture.

Mallet finger is an avulsion of the extensor tendon at its insertion on the base of the distal phalanx, with or without fracture.

Treatment af mallet finger fractures involving more than 1/3 of the articulating surface is controversial. There are to our knowledge no randomized controlled trials comparing splinting and surgical treatment with extension block technique.

The aim of this study is to compare splinting and surgical extension block fixation of mallet finger fractures in a randomized controlled trial.Our hypothesis is that conservative treatment with splinting is comparable to surgical treatment concerning functional outcome, and may even reduce the complication rates.

The original protocol was designed to include participants with non-subluxated and subluxated mallet finger fractures. However this study only included participants with non-subluxated fingers.

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Key information

Conditions

Mallet Finger

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Hand Surgery, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years
  • Mallet finger fractures with a >1mm displaced fragment involving one-third or more of the articular surface and/ or subluxation of the distal phalanges.
  • Fractures with a delay of < 2 weeks.
  • With reference to Wehbé and Schneider's established classification, fractures type IB and IC are included.

Exclusion criteria

  • Open injuries
  • Mallet finger fracture of the thumb
  • Co-existing rheumatologic illness in the fingers
  • No-compliance patient

Treatment and study plan

Conservative treatment with splinting for 6 weeks.

Procedure

Aluminum Karstam splints are used.

Operative treatment with extension block technique

Procedure

Surgery with extension block technique. 6 weeks.

Other names: K-wires (ø= 1 mm) are used.

Primary outcomes

  1. Extension Deficit in the Affected Distal Interphalangeal Joint.

    Time frame: 6 month

    Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)

Secondary outcomes

  1. Pain

    Time frame: 6 month

    Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0-10, with 0 indicating no pain.

  2. Bump

    Time frame: 6 month

    Number of participants with the presence of a bump on the fracture-site.

  3. Complications

    Time frame: 6 month

    Number of participants with nail deformities.

  4. DASH

    Time frame: 6 month

    Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0-100, with 0 indicating no disability.

  5. Flexion of the Distal Interphalangeal Joint.

    Time frame: 6 months

    Flexion of the distal interphalangeal joint. Measured with goniometer.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Ishiguro Extension Block Technique Versus Splinting in the Treatment of Mallet Finger Fracture. A Randomized Controlled Trial.

Acronym: Ishiguro

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Nov 30, 2012
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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