Extension Block Technique Versus Splinting in Mallet Finger Fracture.

Not Applicable

Completed

• Conditions: Mallet Finger
• Interventions: Procedure: Conservative treatment with splinting for 6 weeks.; Procedure: Operative treatment with extension block technique

• Registration Number: NCT01738919
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-30
• Primary Completion: 2015-05
• Results First Submitted: 2016-04-01
• Status Verified: 2016-09
• Study Completion: 2016-09
• Results First Submitted QC: 2016-09-15
• Last Update Submitted: 2016-09-15
• Results First Posted: 2016-11-04
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-subluxated - splinting	Conservative treatment with splinting for 6 weeks.	Conservative treatment with splinting for 6 weeks.
Non-subluxated - operation	Operative treatment with extension block technique	Operative treatment with extension block technique

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain	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.
Bump	6 month	Number of participants with the presence of a bump on the fracture-site.
Complications	6 month	Number of participants with nail deformities.
DASH	6 month	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.	6 months	Flexion of the distal interphalangeal joint. Measured with goniometer.

Trial Locations

Locations (1)

Department of Hand Surgery, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark