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

BMC Musculoskeletal Disorders

Study Protocol

Robert Jan Hillen¹  Niels WL Schep²  Dagmar I Vos³  Maarten WGA Bronkhorst⁴  Bart A van Dijkman⁵  Hub GWM van der Meulen⁶  Freek D Boekhoudt⁷  Piet AR de Rijcke⁸  Gert R Roukema⁹  Ger DJ van Olden^1,10  Johan GH van den Brand^1,11  Jan Paul M Frölke^1,12  Mark R de Vries^1,13  Jephta van den Bremer^1,14  Andras FK Tanka^1,15  Martin G Eversdijk^1,16  Tom PH van Thiel^1,17  Stephan WAM van Zutphen^1,18  Nicolaj MR Soesman^1,19  Tjebbe Hagenaars^2,20  Inger B Schipper^2,21  Mireille de Jong^2,21  Jan W Duijff^2,21  Sylvia A Stegeman^2,21  Cornelis FM Sier^2,21  Pieta Krijnen^2,21 

[1] Department of Orthopaedics, Waterland Hospital, P.O. box 250, 1440 AG Purmerend, The Netherlands;Department of Surgery, Academic Medical Centre, P.O. box 22660, 1100 DD, Amsterdam, The Netherlands;Department of Surgery, Amphia Hospital, P.O. box 90158, 4800 RK, Breda, The Netherlands;Department of Surgery, Bronovo Hospital, P.O. box 96900, 2509 JH, The Hague, The Netherlands;Department of Surgery, Flevo Hospital, P.O. box 3005, 1300 EG, Almere, The Netherlands;Department of Surgery, Haga Hospital, P.O. box 40551, 2504 LN, The Hague, The Netherlands;Department of Surgery, Hospital Gelderse Vallei, P.O. box 9025, 6710 HN Ede, The Netherlands;Department of Surgery, IJsselland Hospital, P.O. box 690, 2900 AR Capelle a/d IJssel, The Netherlands;Department of Surgery, Maasstad Hospital, P.O. box 9100, 3007, AC Rotterdam, The Netherlands;Department of Surgery, Meander Medical Centre, P.O. box 1502, 3800 BM, mersfoort, The Netherlands;Department of Surgery, Medical Centre Alkmaar, P.O. box 501, 1800 AM Alkmaar, The Netherlands;Department of Surgery, Radboud University Nijmegen Medical Centre, P.O. box 9101, 6500, HB Nijmegen, The Netherlands;Department of Surgery, Reinier de Graaf Group, P.O. box 5011, 2600 GA, Delft, The Netherlands;Department of Surgery, Rijnland Hospital, P.O. box 4220, 2350 CC, Leiderdorp, The Netherlands;Department of Surgery, Spaarne Hospital, P.O. box 770, 2130 AT, Hoofddorp, The Netherlands;Department of Surgery, St Jansdal Hospital, P.O. box 138, 3840 AC, Harderwijk, The Netherlands;Department of Surgery, Streekziekenhuis Koningin Beatrix, P.O. box 9005, 7100, GG Winterswijk, The Netherlands;Department of Surgery, Tweesteden Hospital, P.O. box 90107, 5000 LA, Tilburg, The Netherlands;Department of Surgery, Vlietland Hospital, P.O. box 215, 3100, AE Schiedam, The Netherlands;Department of Surgery-Traumatology, Erasmus Medical Centre, P.O. box 2040, 3000, CA Rotterdam, The Netherlands;Department of Surgery-Traumatology, Leiden University Medical Centre, P.O. box 9600, 2300, RC Leiden, The Netherlands;

关键词: Plate Fixation;    Constant Score;    Multicentre Randomise Control Trial;    Clavicular Fracture;    Lock Plate Fixation;   

DOI  :  10.1186/1471-2474-12-196

 received in 2011-05-19, accepted in 2011-08-24,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundThe 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.AimA 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/designA 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.DiscussionThis 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 registrationNetherlands National Trial Register NTR2399

【 授权许可】

CC BY   
© Stegeman et al; licensee BioMed Central Ltd. 2011