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Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial
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  • 作者：Sylvia A Stegeman (1)
    Mireille de Jong (1)
    Cornelis FM Sier (1)
    Pieta Krijnen (1)
    Jan W Duijff (1)
    Tom PH van Thiel (2)
    Piet AR de Rijcke (3)
    Nicolaj MR Soesman (4)
    Tjebbe Hagenaars (5)
    Freek D Boekhoudt (6)
    Mark R de Vries (7)
    Gert R Roukema (8)
    Andras FK Tanka (9)
    Jephta van den Bremer (10)
    Hub GWM van der Meulen (11)
    Maarten WGA Bronkhorst (12)
    Bart A van Dijkman (13)
    Stephan WAM van Zutphen (14)
    Dagmar I Vos (15)
    Niels WL Schep (16)
    Martin G Eversdijk (17)
    Ger DJ van Olden (18)
    Johan GH van den Brand (19)
    Robert Jan Hillen (20)
    Jan Paul M Fr?lke (21)
    Inger B Schipper (1)
  • 刊名：BMC Musculoskeletal Disorders
  • 出版年：2011
  • 出版时间：December 2011
  • 年：2011
  • 卷：12
  • 期：1
  • 全文大小：238KB
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    36. Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C: Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. / J Hand Ther 2001, 14:128-46.
    37. Hudak PL, Amadio PC, Bombardier C: Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). / Am J Ind Med 1996, 29:602-08. CrossRef
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    40. The pre-publication history for this paper can be accessed here:www.biomedcentral.com/1471-2474/12/196/prepub" class="a-plus-plus">http://www.biomedcentral.com/1471-2474/12/196/prepub
  • 作者单位：Sylvia A Stegeman (1)
    Mireille de Jong (1)
    Cornelis FM Sier (1)
    Pieta Krijnen (1)
    Jan W Duijff (1)
    Tom PH van Thiel (2)
    Piet AR de Rijcke (3)
    Nicolaj MR Soesman (4)
    Tjebbe Hagenaars (5)
    Freek D Boekhoudt (6)
    Mark R de Vries (7)
    Gert R Roukema (8)
    Andras FK Tanka (9)
    Jephta van den Bremer (10)
    Hub GWM van der Meulen (11)
    Maarten WGA Bronkhorst (12)
    Bart A van Dijkman (13)
    Stephan WAM van Zutphen (14)
    Dagmar I Vos (15)
    Niels WL Schep (16)
    Martin G Eversdijk (17)
    Ger DJ van Olden (18)
    Johan GH van den Brand (19)
    Robert Jan Hillen (20)
    Jan Paul M Fr?lke (21)
    Inger B Schipper (1)

    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
文摘
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

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