1. HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER): a multicenter comparative observational study.
- Author
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Mahabier KC, Van Lieshout EM, Bolhuis HW, Bos PK, Bronkhorst MW, Bruijninckx MM, De Haan J, Deenik AR, Dwars BJ, Eversdijk MG, Goslings JC, Haverlag R, Heetveld MJ, Kerver AJ, Kolkman KA, Leenhouts PA, Meylaerts SA, Onstenk R, Poeze M, Poolman RW, Punt BJ, Roerdink WH, Roukema GR, Sintenie JB, Soesman NM, Tanka AK, Ten Holder EJ, Van der Elst M, Van der Heijden FH, Van der Linden FM, Van der Zwaal P, Van Dijk JP, Van Jonbergen HP, Verleisdonk EJ, Vroemen JP, Waleboer M, Wittich P, Zuidema WP, Polinder S, Verhofstad MH, and Den Hartog D
- Subjects
- Activities of Daily Living, Clinical Protocols, Cost-Benefit Analysis, Disability Evaluation, Fracture Fixation economics, Health Care Costs, Humans, Humeral Fractures diagnosis, Humeral Fractures economics, Humeral Fractures physiopathology, Humeral Fractures surgery, Netherlands, Pain Measurement, Prospective Studies, Recovery of Function, Return to Work, Surveys and Questionnaires, Time Factors, Treatment Outcome, Fracture Fixation methods, Fracture Healing, Humeral Fractures therapy, Research Design
- 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).
- Published
- 2014
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