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

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

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.

Study Overview

• Status: Completed
• Conditions: Mallet Finger
• Intervention / Treatment: Procedure: Conservative treatment with splinting for 6 weeks.; Procedure: Operative treatment with extension block technique

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Department of Hand Surgery, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: K-wires (ø= 1 mm) are used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extension Deficit in the Affected Distal Interphalangeal Joint.	Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0-10, with 0 indicating no pain.	6 month
Bump	Number of participants with the presence of a bump on the fracture-site.	6 month
Complications	Number of participants with nail deformities.	6 month
DASH	Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0-100, with 0 indicating no disability.	6 month
Flexion of the Distal Interphalangeal Joint.	Flexion of the distal interphalangeal joint. Measured with goniometer.	6 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Chair: Bo Munk, MD, Department of Hand Surgery, Aarhus University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: November 28, 2012
• First Submitted That Met QC Criteria: November 28, 2012
• First Posted (Estimate): November 30, 2012

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: September 15, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Janni1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO