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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

A comparison of intervention and conservative treatment for angulated fractures of the distal forearm in children (AFIC): study protocol for a randomized controlled trial

Authors: Miriam Adrian, Daniel Wachtlin, Kai Kronfeld, Dirk Sommerfeldt, Lucas M. Wessel

Published in: Trials | Issue 1/2015

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Abstract

Background

Angulated fractures of the distal forearm are very frequent lesions in childhood. Currently, there are no standard guidelines on whether these children should be treated conservatively with a cast; with reduction and a cast; or with reduction, pinning and a cast under anesthesia.
Minor prospective and retrospective studies have shown that the distal physis of the forearm possesses high remodeling capacity leading to reliable correction of malalignment.
The aim of this trial is to answer the question about whether operative and conservative treatment show equivocal results.

Methods/Design

This is a prospective, multinational, multicenter, randomized, observer-blinded, actively controlled, parallel group trial, with 24 months of observation.
The primary objective of this trial is to assess whether or not the long-term functional outcome in remodeling patients is inferior to patients receiving closed reduction and K-wire pinning.
The trial should include 742 patients with acute fracture. The patients will be included in 30 medical centers in Germany, Switzerland and Austria.
All patients 5 to 11 years of age presenting at the emergency department with an angulated distal fracture of the forearm will be randomized online after informed consent.
The primary endpoint is the Cooney Score after 24 months. The secondary endpoint is the grade of radiological displacement at 12/24 months.

Discussion

Therapy of angulated fractures is a matter of intensive debate. Primary manipulation and pinning under general anesthesia is recommended in order to avoid malalignment. No major study has proven the advantage of manipulation and pinning over immobilization alone. Should remodeling appear to be a safe alternative, manipulation under general anesthesia, K-wire pinning and removal of pins could be avoided, thus sparing significant costs.

Trial registration

DRKS00004874, 30 October 2013.
Literature
1.
Abraham A, Handoll HH, Khan T. Interventions for treating wrist fractures in children. Cochrane Database Syst Rev. 2008;16:CD004576.
2.
Al-Ansari K, Howard A, Seeto B, Yoo S, Zaki S, Boutis K. Minimally angulated paediatric wrist fractures: is immobilization without manipulation enough? CJEM. 2007;9:9–15.
3.
Brudvik C, Hove LM. Childhood fractures in Bergen, Norway: identifying high-risk groups and activities. JPediatr Orthop. 2003;23:629–34.
4.
Clavien PA, Barkun J, de Oliveira ML, Vauthney JN, Dindo D, Schulick RD, et al. The Clavien-Dindoclassification of surgical complications: five-year experience. Ann Surg. 2009;250(2):187–96.
5.
Cooney WP 3rd, Linscheid RL, Dobyns JH. External pin fixation for unstable Colles’ fractures. J BoneJoint Surg Am. 1979;61:840–5.
6.
Cooper C, Dennison EM, Leufkens HG, Bishop N, van Staa TP. Epidemiology of childhood fractures inBritain: a study using the general practise research database. JBone Miner Res. 2004;19:1976–81.
7.
Cotè CJ, Karl HW, Nottermann DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: acritical incident analysis of contributing factors. Pediatrics. 2000:105;805–14.
8.
Crawford SN, Lee LSK, Izuka BH. Closed treatment of overriding distal radial fractures without reductionin children. JBone Joint Surg [Am] 2012:94;246–52.
9.
Farrington CP, Manning G (1990). Test statistics and sample size formulae for comparative binomial trialswith null hypothesis of non-zero risk difference or non-unity relative risk. Statistics in Medicine 9, 1447-1454.
10.
Hove LM, Brudvic C. Displaced paediatric fractures oft he distal radius. Arch Orthop Trauma Surg 2008;128:55–60.
11.
Krimmer H, Wilmer P: Vergleichende Ergebnisbewertung am Handgelenk-mediokarpale Teilarthrodeseund Totalarthrodese. Handchir Mikrochir Plast Chir. 2000;32:369–374.
12.
Laurer H, Sander A, Wutzler S, Walcher F, Marzi I. Therapieprinzipien distaler Unterarmfrakturen imKindesalter. Chirurg. 2009;80:1042–52.
13.
Luscombe KL, Chaudhry S, Dwyer JS, Shanmugam C, Mafulli N. Selective Kirschner wiring fordisplaced distal radial fractures in children. Acta Orthop Traumatol Turc. 2010;44:117–23.
14.
Planka L, Chalupova P, Skvaril J, Poul J, Gal P. Remodelling ability of the distal radius in fracturehealing in childhood. Rhozhl Chir. 2006;85:508–10.
15.
Proctor MT, Moore DJ, Paterson JM. Redisplacement after manipulation of distal radial fractures inchildren. J Bone Jt Surg. 1993;75:453–4.
16.
Roback MG, Wathen JE, Bajaj L,Bothner JP. Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs. Acad EmergMed. 2005;12:508–13.
17.
Rockwood CA, Wilkins KE, Beaty JH (eds.) Fractures in Children. Lippincot New York 2006.
Metadata
Title
A comparison of intervention and conservative treatment for angulated fractures of the distal forearm in children (AFIC): study protocol for a randomized controlled trial
Authors
Miriam Adrian
Daniel Wachtlin
Kai Kronfeld
Dirk Sommerfeldt
Lucas M. Wessel
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0912-x

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