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

Autor: M.G. Eversdijk, Egbert J M M Verleisdonk, Michael H.J. Verhofstad, P. Koen Bos, Axel R Deenik, Gert R. Roukema, Martin J. Heetveld, J. Carel Goslings, Jan Bernard Sintenie, M.W.G.A. Bronkhorst, Jan P. Van Dijk, Kiran C. Mahabier, Albert J.H. Kerver, Jeroen de Haan, S. A. G. Meylaerts, Martijn Poeze, Hans-Peter W. van Jonbergen, Frank H.W.M. Van der Heijden, Peter A. Leenhouts, Esther M.M. Van Lieshout, Edgar J T Ten Holder, Wietse P. Zuidema, Robert Haverlag, Suzanne Polinder, Ron Onstenk, Rudolf W. Poolman, Peer van der Zwaal, Frits M. Van der Linden, Milko M.M. Bruijninckx, Boudewijn J Dwars, J.P.A.M. Vroemen, Marco Waleboer, Bas J. Punt, Dennis den Hartog, Andras K F Tanka, Nicolaj M R Soesman, Hugo W. Bolhuis, W Herbert Roerdink, Philippe Wittich, K. A. Kolkman, Maarten Van der Elst
Přispěvatelé: Surgery, Other Research, AMS - Amsterdam Movement Sciences, Other departments, Obstetrie & Gynaecologie, RS: NUTRIM - R2 - Gut-liver homeostasis, Orthopedics and Sports Medicine, Public Health
Rok vydání: 2014
Předmět:
Zdroj: BMC Musculoskeletal Disorders, 15:39. BioMed Central
BMC Musculoskeletal Disorders
BMC musculoskeletal disorders, 15(1). BioMed Central
BMC Musculoskeletal Disorders, 15:39. BioMed Central Ltd
Mahabier, K C, van Lieshout, E M M, Bolhuis, H W, Bos, P K, Bronkhorst, M W G A, Bruijninckx, M M M, de Haan, J, Deenik, A R, Dwars, B J, Eversdijk, M G, Goslings, J C, Haverlag, R, Heetveld, M J, Kerver, A J H, Kolkman, K A, Leenhouts, P A, Meylaerts, S A G, Onstenk, R, Poeze, M, Poolman, R W, Punt, B J, Roerdink, W H, Roukema, G R, Sintenie, J B, Soesman, N M R, Tanka, A K F, Ten Holder, E J T, van der Elst, M, Van der Heijden, F H W M, Van der Linden, F M, Van der Zwaal, P, van Dijk, J P, Van Jonbergen, H P W, Verleisdonk, E J M M, Vroemen, J P A M, Waleboer, M, Wittich, P, Zuidema, W P, Polinder, S, Verhofstad, M H J & Den Hartog, D 2014, ' HUMeral Shaft Fractures: MEasuring Recovery after Operative versus Non-operative Treatment (HUMMER): a multicenter comparative observational study ', BMC Musculoskeletal Disorders, vol. 15, 39 . https://doi.org/10.1186/1471-2474-15-39
BioMed Central, 15(1):39. BioMed Central Ltd.
ISSN: 1471-2474
Popis: 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).
Databáze: OpenAIRE
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