Conservative Therapy of Proximal Phalanx Fractures - Comparing the Lucerne Cast With Finger Splinting

Study Overview
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Brief Summary
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The purpose of this prospective randomized controlled clinical trial is to evaluate if the lucerne cast leads to a better functional outcome than a forearm cast with a finger splint in patients with a proximal phalanx fracture.

Detailed Description
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This study represents a prospective randomized controlled clinical trial comparing two different conservative treatment options in patients with proximal phalanx fractures. Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Randomization will be performed according to the CONSORT Guidelines of Prospective Randomized Trials using the software Randomizer by the Medical University of Graz. Patients allocated to the control group will receive a forearm cast with a finger splint, while patients in the study group will receive the lucerne cast. Both groups will receive the allocated cast for 4 weeks. Clinical outcome will be assessed 12 weeks after trauma.

Official Title
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Conservative Therapy of Proximal Phalanx Fractures - a Prospective Randomized Study Comparing the Lucerne Cast With Finger Splinting

Conditions
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Proximal Phalanx Fracture

Intervention / Treatment
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* Procedure: Lucerne Cast
* Procedure: Forearm Cast and Finger Splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proximal phalanx fracture in the fingers (II - V) Patient age between 18 and 70 years Exclusion Criteria: Condylar fracture Avulsions of the collateral ligament Pathologic fracture Intraarticular fracture Patients unable to consent Polytraumatized patients Patients initially presenting more than 7 days after injury Pregnancy Compound fractures Multiple hand injuries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lucerne Cast<br> | Procedure: Lucerne Cast<br>* Patients receiving reduction of fractured finger and subsequent customization of a lucerne cast. Duration of cast treatment is determined with 4 weeks.<br>|
| Active Comparator: Forearm Cast and Finger Splint<br> | Procedure: Forearm Cast and Finger Splint<br>* Patients receiving reduction of fractured finger and subsequent customization of a forearm cast with a finger splint. Duration of cast treatment is determined with 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Michigan-Hand-Outcome-Questionnaire | patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function) | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Failure | Occurrence of indication for surgery (malrotation, axial deviation >10°, dorsal angulation >20°) after primary reposition | at 1, 2, 4 and 12 weeks |