Extension Block Technique Versus Splinting in Mallet Finger Fracture.

NCT ID: NCT01738919

Last Updated: 2016-11-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Mallet Finger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Non-subluxated - splinting

Conservative treatment with splinting for 6 weeks.

Group Type ACTIVE_COMPARATOR

Conservative treatment with splinting for 6 weeks.

Intervention Type PROCEDURE

Aluminum Karstam splints are used.

Non-subluxated - operation

Operative treatment with extension block technique

Group Type ACTIVE_COMPARATOR

Operative treatment with extension block technique

Intervention Type PROCEDURE

Surgery with extension block technique. 6 weeks.

Interventions

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Conservative treatment with splinting for 6 weeks.

Aluminum Karstam splints are used.

Intervention Type PROCEDURE

Operative treatment with extension block technique

Surgery with extension block technique. 6 weeks.

Intervention Type PROCEDURE

Other Intervention Names

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K-wires (ø= 1 mm) are used.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bo Munk, MD

Role: STUDY_CHAIR

Department of Hand Surgery, Aarhus University Hospital, Denmark

Locations

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Department of Hand Surgery, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Janni1

Identifier Type: -

Identifier Source: org_study_id