Func tional treatment versus plaster for si mple el bow dislocations (FuncSiE): a randomized trial

Jos De Haan ,Marco Waleboer,Dennis Den Hartog,Robert Haverlag,Denise Eygendaal,Suzanne Polinder,Jan Bernard Sintenie,Inger B Schipper ,Tom P H Van Thiel ,A.b Van Vugt ,W Jaap Willems ,Jan‐Willem R Mulder ,S Sivro ,J.p.a.m Vroemen ,W.h Roerdink ,G.i.t Iordens ,M.m.m Bruijninckx ,Johan G H Van Den Brand ,W.e Tuinebreijer ,S.a.g Meylaerts ,Gert R Roukema ,Mark R De Vries ,M Schouten ,Esther M.m Van Lieshout ,E J M M Verleisdonk ,P Patka ,Boudewijn J Dwars ,R.s Breederveld ,M.w.g.a Bronkhorst ,H.g.w.m Meulen ,Kees Jan Ponsen ,N.w.l Schep

doi:10.1186/1471-2474-11-263

Abstract

BackgroundElbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow.Methods/DesignThe design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for pro-supination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford elbow score, pain level at both sides, range of motion of the elbow joint at both sides, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation), health-related quality of life (Short-Form 36 and EuroQol-5D), radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications), costs, and cost-effectiveness.DiscussionThe successful completion of this trial will provide evidence on the effectiveness of a functional treatment for the management of simple elbow dislocations.Trial RegistrationThe trial is registered at the Netherlands Trial Register (NTR2025).

Highlights

Elbow dislocations can be classified as simple or complex
Recruitment and consent Eligible patients presenting to the emergency department (ED) with a simple elbow dislocation will be informed about the trial at the ED after reduction of the dislocated elbow
Functional treatment may lead to a better range of motion (ROM) and prevent elbow stiffness

Summary

Introduction

Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. Elbow dislocations are classified as simple or complex [2]. Conn et al observed 414 injuries of the elbow, which included 58 elbow dislocations in both children and adults [3]. Josefsson et al observed 24 simple elbow dislocations in 52 patients (46%) who were 16 years old and older [4]

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