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Open Access Study protocol

Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial

Sylvia A Stegeman1*, Mireille de Jong1, Cornelis FM Sier1, Pieta Krijnen1, Jan W Duijff1, Tom PH van Thiel2, Piet AR de Rijcke3, Nicolaj MR Soesman4, Tjebbe Hagenaars5, Freek D Boekhoudt6, Mark R de Vries7, Gert R Roukema8, Andras FK Tanka9, Jephta van den Bremer10, Hub GWM van der Meulen11, Maarten WGA Bronkhorst12, Bart A van Dijkman13, Stephan WAM van Zutphen14, Dagmar I Vos15, Niels WL Schep16, Martin G Eversdijk17, Ger DJ van Olden18, Johan GH van den Brand19, Robert Jan Hillen20, Jan Paul M Frölke21 and Inger B Schipper1

Author Affiliations

1 Department of Surgery-Traumatology, Leiden University Medical Centre, P.O. box 9600, 2300 RC Leiden, the Netherlands

2 Department of Surgery, Streekziekenhuis Koningin Beatrix, P.O. box 9005, 7100 GG Winterswijk, the Netherlands

3 Department of Surgery, IJsselland Hospital, P.O. box 690, 2900 AR Capelle a/d IJssel, the Netherlands

4 Department of Surgery, Vlietland Hospital, P.O. box 215, 3100 AE Schiedam, the Netherlands

5 Department of Surgery-Traumatology, Erasmus Medical Centre, P.O. box 2040, 3000 CA Rotterdam, the Netherlands

6 Department of Surgery, Hospital Gelderse Vallei, P.O. box 9025, 6710 HN Ede, the Netherlands

7 Department of Surgery, Reinier de Graaf Group, P.O. box 5011, 2600 GA Delft, the Netherlands

8 Department of Surgery, Maasstad Hospital, P.O. box 9100, 3007 AC Rotterdam, the Netherlands

9 Department of Surgery, Spaarne Hospital, P.O. box 770, 2130 AT Hoofddorp, the Netherlands

10 Department of Surgery, Rijnland Hospital, P.O. box 4220, 2350 CC Leiderdorp, the Netherlands

11 Department of Surgery, Haga Hospital, P.O. box 40551, 2504 LN The Hague, the Netherlands

12 Department of Surgery, Bronovo Hospital, P.O. box 96900, 2509 JH The Hague, the Netherlands

13 Department of Surgery, Flevo Hospital, P.O. box 3005, 1300 EG, Almere, the Netherlands

14 Department of Surgery, Tweesteden Hospital, P.O. box 90107, 5000 LA Tilburg, the Netherlands

15 Department of Surgery, Amphia Hospital, P.O. box 90158, 4800 RK Breda, the Netherlands

16 Department of Surgery, Academic Medical Centre, P.O. box 22660, 1100 DD Amsterdam, the Netherlands

17 Department of Surgery, St Jansdal Hospital, P.O. box 138, 3840 AC Harderwijk, the Netherlands

18 Department of Surgery, Meander Medical Centre, P.O. box 1502, 3800 BM Amersfoort, the Netherlands

19 Department of Surgery, Medical Centre Alkmaar, P.O. box 501, 1800 AM Alkmaar, the Netherlands

20 Department of Orthopaedics, Waterland Hospital, P.O. box 250, 1440 AG Purmerend, the Netherlands

21 Department of Surgery, Radboud University Nijmegen Medical Centre, P.O. box 9101, 6500 HB Nijmegen, the Netherlands

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BMC Musculoskeletal Disorders 2011, 12:196  doi:10.1186/1471-2474-12-196

Published: 24 August 2011

Abstract

Background

The traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures. Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries.

Aim

A prospective, multicentre randomised controlled trial (RCT) will be conducted in 21 hospitals in the Netherlands, comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation.

Methods/design

A total of 350 patients will be included, between 18 and 60 years of age, with a dislocated midshaft clavicular fracture. The primary outcome is the incidence of non-union, which will be determined with standardised X-rays (Antero-Posterior and 30 degrees caudocephalad view). Secondary outcome will be the functional outcome, measured using the Constant Score. Strength of the shoulder muscles will be measured with a handheld dynamometer (MicroFET2). Furthermore, the health-related Quality of Life score (ShortForm-36) and the Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure will be monitored as subjective parameters. Data on complications, bone union, cosmetic aspects and use of painkillers will be collected with follow-up questionnaires. The follow-up time will be two years. All patients will be monitored at regular intervals over the subsequent twelve months (two and six weeks, three months and one year). After two years an interview by telephone and a written survey will be performed to evaluate the two-year functional and mechanical outcomes. All data will be analysed on an intention-to-treat basis, using univariate and multivariate analyses.

Discussion

This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two standardised treatment options for dislocated midshaft clavicular fractures. The gathered data may support the development of a clinical guideline for treatment of clavicular fractures.

Trial registration

Netherlands National Trial Register NTR2399