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Open Access Study protocol

HUMeral Shaft Fractures: MEasuring Recovery after Operative versus Non-operative Treatment (HUMMER): a multicenter comparative observational study

Kiran C Mahabier1, Esther MM Van Lieshout1*, Hugo W Bolhuis2, P Koen Bos3, Maarten WGA Bronkhorst4, Milko MM Bruijninckx5, Jeroen De Haan6, Axel R Deenik7, Boudewijn J Dwars8, Martin G Eversdijk9, J Carel Goslings10, Robert Haverlag11, Martin J Heetveld12, Albert JH Kerver13, Karel A Kolkman14, Peter A Leenhouts15, Sven AG Meylaerts16, Ron Onstenk17, Martijn Poeze18, Rudolf W Poolman19, Bas J Punt20, W Herbert Roerdink21, Gert R Roukema22, Jan Bernard Sintenie23, Nicolaj MR Soesman24, Andras KF Tanka25, Edgar JT Ten Holder26, Maarten Van der Elst27, Frank HWM Van der Heijden28, Frits M Van der Linden29, Peer Van der Zwaal30, Jan P Van Dijk31, Hans-Peter W Van Jonbergen32, Egbert JMM Verleisdonk33, Jos PAM Vroemen34, Marco Waleboer35, Philippe Wittich36, Wietse P Zuidema37, Suzanne Polinder38, Michael HJ Verhofstad1 and Dennis Den Hartog1

Author Affiliations

1 Trauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands

2 Department of Surgery, Gelre Hospital, P.O. Box 9014, 7300 DS Apeldoorn, The Netherlands

3 Department of Orthopaedic Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands

4 Department of Surgery, Bronovo Hospital, P.O. Box 96900, 2509 JH The Hague, The Netherlands

5 Department of Surgery, IJsselland Hospital, P.O. Box 690, 2900 AR Capelle a/d IJssel, The Netherlands

6 Department of Surgery, Westfriesgasthuis, P.O. Box 600, 1620 AR Hoorn, The Netherlands

7 Department of Orthopaedic Surgery, Bronovo Hospital, P.O. Box 96900, 2509 JH The Hague, The Netherlands

8 Department of Surgery, Slotervaart Hospital, P.O. Box 90440, 1006 BK Amsterdam, The Netherlands

9 Department of Surgery, St. Jansdal Hospital, P.O. Box 138, 3840 AC Harderwijk, The Netherlands

10 Trauma Unit Department of Surgery, Academic Medical Center, P.O. Box 22660, 1100 DD Amsterdam, The Netherlands

11 Department of Surgery, Onze Lieve Vrouwe Gasthuis, P.O. Box 95500, 1090 HM Amsterdam, The Netherlands

12 Department of Surgery, Kennemer Gasthuis, P.O. Box 417, 2000 AK Haarlem, The Netherlands

13 Department of Surgery, Sint Franciscus Gasthuis, P.O. Box 10900, 3004 BA Rotterdam, The Netherlands

14 Department of Surgery, Rijnstate, P.O. Box 9555, 6800 TA Arnhem, The Netherlands

15 Department of Surgery, Zaans Medical Center, P.O. Box 210, 1500 EE Zaandam, The Netherlands

16 Department of Surgery, Medical Center Haaglanden, P.O. Box 432, 2501 CK The Hague, The Netherlands

17 Department of Orthopaedic Surgery, Groene Hart Ziekenhuis, P.O. Box 1098, 2800 BB Gouda, The Netherlands

18 Department of Trauma Surgery, Maastricht University Medical Center, PO Box 5800, 6202 AZ Maastricht, The Netherlands

19 Department of Orthopaedic Surgery, Onze Lieve Vrouwe Gasthuis, P.O. Box 95500, 1090 HM Amsterdam, The Netherlands

20 Department of Surgery, Albert Schweitzer Hospital, P.O. Box 444, 3300 AK Dordrecht, The Netherlands

21 Department of Surgery, Deventer Hospital, P.O. Box 5001, 7400 GC Deventer, The Netherlands

22 Department of Surgery, Maasstad Hospital, P.O. Box 9100, 3007 AC Rotterdam, The Netherlands

23 Department of Surgery, Elkerliek Hospital, P.O. Box 98, 5700 AB Helmond, The Netherlands

24 Department of Surgery, Vlietland Hospital, P.O. Box 215, 3100 AE Schiedam, The Netherlands

25 Department of Surgery, Spaarne Hospital, P.O. Box 770, 2130 AT Hoofddorp, The Netherlands

26 Department of Orthopaedic Surgery, IJsselland Hospital, P.O. Box 690, 2900 AR Capelle a/d IJssel, The Netherlands

27 Department of Surgery, Reinier de Graaf Gasthuis, P.O. Box 5011, 2600 GA Delft, The Netherlands

28 Department of Surgery, St Elisabeth Hospital, P.O. Box 90151, 5000 LC Tilburg, The Netherlands

29 Department of Surgery, Groene Hart Ziekenhuis, P.O. Box 1098, 2800 BB Gouda, The Netherlands

30 Department of Orthopaedic Surgery, Medical Center Haaglanden, P.O. Box 432, 2501 CK The Hague, The Netherlands

31 Department of Surgery, Hospital Gelderse Vallei, P.O. Box 9025, 6710 HN Ede, The Netherlands

32 Department of Orthopaedic Surgery, Deventer Hospital, P.O. Box 5001, 7400 GC Deventer, The Netherlands

33 Department of Surgery, Diakonessenhuis, P.O. Box 80250, 3508 TG Utrecht, The Netherlands

34 Department of Surgery, Amphia Hospital, P.O. Box 90158, 4800 RK Breda, The Netherlands

35 Department of Surgery, Admiraal de Ruyter Hospital, P.O. Box 106, 4460 BB Goes, The Netherlands

36 Department of Surgery, St. Antonius Hospital, P.O. Box 2500, 3430 EM Nieuwegein, The Netherlands

37 Department of Trauma Surgery, VU University Medical Center, P.O. Box 7057, 1007 MB Amsterdam, The Netherlands

38 Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands

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BMC Musculoskeletal Disorders 2014, 15:39  doi:10.1186/1471-2474-15-39

Published: 11 February 2014

Abstract

Background

Fractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery.

Methods/design

The design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective.

Discussion

Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture.

Trial registration

The trial is registered at the Netherlands Trial Register (NTR3617).