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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01738919
First received: November 28, 2012
Last updated: September 15, 2016
Last verified: September 2016
  Purpose

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 Intervention
Mallet Finger
Procedure: Conservative treatment with splinting for 6 weeks.
Procedure: Operative treatment with extension block technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Extension Deficit in the Affected Distal Interphalangeal Joint. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)


Secondary Outcome Measures:
  • Pain [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0-10, with 0 indicating no pain.

  • Bump [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Number of participants with the presence of a bump on the fracture-site.

  • Complications [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Number of participants with nail deformities.

  • DASH [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0-100, with 0 indicating no disability.

  • Flexion of the Distal Interphalangeal Joint. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Flexion of the distal interphalangeal joint. Measured with goniometer.


Enrollment: 32
Study Start Date: April 2011
Study Completion Date: September 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01738919     History of Changes
Other Study ID Numbers: Janni1 
Study First Received: November 28, 2012
Results First Received: April 1, 2016
Last Updated: September 15, 2016
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on December 02, 2016