Extension Block Technique Versus Splinting in Mallet Finger Fracture.

Study Overview
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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.

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

Conditions
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Mallet Finger

Intervention / Treatment
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* Procedure: Conservative treatment with splinting for 6 weeks.
* Procedure: Operative treatment with extension block technique


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-subluxated - splinting<br>Conservative treatment with splinting for 6 weeks. | Procedure: Conservative treatment with splinting for 6 weeks.<br>* Aluminum Karstam splints are used.<br>|
| Active Comparator: Non-subluxated - operation<br>Operative treatment with extension block technique | Procedure: Operative treatment with extension block technique<br>* Surgery with extension block technique. 6 weeks.<br>* Other names: K-wires (ø= 1 mm) are used.;|

What is the study measuring?
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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 |