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Extension Block Technique Versus Splinting in Mallet Finger Fracture. (Ishiguro)

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ClinicalTrials.gov Identifier: NCT01738919
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : November 4, 2016
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mallet Finger Procedure: Conservative treatment with splinting for 6 weeks. Procedure: Operative treatment with extension block technique Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Ishiguro Extension Block Technique Versus Splinting in the Treatment of Mallet Finger Fracture. A Randomized Controlled Trial.
Study Start Date : April 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Non-subluxated - splinting
Conservative treatment with splinting for 6 weeks.
Procedure: Conservative treatment with splinting for 6 weeks.
Aluminum Karstam splints are used.
Active Comparator: Non-subluxated - operation
Operative treatment with extension block technique
Procedure: Operative treatment with extension block technique
Surgery with extension block technique. 6 weeks.
Other Name: K-wires (ø= 1 mm) are used.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01738919


Locations
Denmark
Department of Hand Surgery, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Bo Munk, MD Department of Hand Surgery, Aarhus University Hospital, Denmark

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01738919     History of Changes
Other Study ID Numbers: Janni1
First Posted: November 30, 2012    Key Record Dates
Results First Posted: November 4, 2016
Last Update Posted: November 4, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No