Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon): A Multicenter Randomized Controlled trial

BMC Musculoskeletal Disorders

Study Protocol

Harm M Van der Vis¹  Suzanne Polinder²  Ed F Van Beeck²  Maarten WGA Bronkhorst³  W Herbert Roerdink⁴  Steven Rhemrev⁵  Roelf S Breederveld⁶  Gerrit Schraa⁷  Thom PH Van Thiel⁸  Jan Peter Eerenberg⁹  Dennis Den Hartog^1,10  Esther MM Van Lieshout^1,10  Niels WL Schep^1,10  Wim E Tuinebreijer^1,10  Peter Patka^1,10  Stefaan Nijs^1,11 

[1] Department of Orthopedic Surgery, Tergooi Hospitals, P.O. Box 10016, 1201 DA, Hilversum, The Netherlands;Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands;Department of Surgery, Bronovo Hospital, P.O. Box 96900, 2509 JH, The Hague, The Netherlands;Department of Surgery, Deventer Hospital, P.O. Box 50017400 GC, Deventer, The Netherlands;Department of Surgery, Medical Center Haaglanden, P.O. Box 432, 2501 CK, The Hague, The Netherlands;Department of Surgery, Red Cross Hospital, P.O. Box 1074, 1940 EB, Beverwijk, 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, Tergooi Hospitals, P.O. Box 10016, 1201 DA, Hilversum, The Netherlands;Department of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands;Department of Traumatology, UZ Leuven, Herestraat 49, 3000, Leuven, Leuven, Belgium;

关键词: Humeral Head;    Proximal Humerus;    Constant Score;    Proximal Humeral Fracture;    Comminute Fracture;   

DOI  :  10.1186/1471-2474-11-97

 received in 2010-05-04, accepted in 2010-05-25,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundFractures of the proximal humerus are associated with a profound temporary and sometimes permanent, impairment of function and quality of life. The treatment of comminuted fractures of the proximal humerus like selected three-or four-part fractures and split fractures of the humeral head is a demanding and unresolved problem, especially in the elderly. Locking plates appear to offer improved fixation; however, screw cut-out rates ranges due to fracture collapse are high. As this may lead to higher rates of revision surgery, it may be preferable to treat comminuted fractures in the elderly primarily with a prosthesis or non-operatively. Results from case series and a small-sample randomized controlled trial (RCT) suggest improved function and less pain after primary hemiarthroplasty (HA); however these studies had some limitations and a RCT is needed. The primary aim of this study is to compare the Constant scores (reflecting functional outcome and pain) at one year after primary HA versus non-operative treatment in elderly patients who sustained a comminuted proximal humeral fracture. Secondary aims include effects on functional outcome, pain, complications, quality of life, and cost-effectiveness.Methods/DesignA prospective, multi-center RCT will be conducted in nine centers in the Netherlands and Belgium. Eighty patients over 65 years of age, who have sustained a three-or four part, or split head proximal humeral fracture will be randomized between primary hemiarthroplasty and conservative treatment. The primary outcome is the Constant score, which indicates pain and function. Secondary outcomes include the Disability of the Arm and Shoulder (DASH) score, Visual Analogue Scale (VAS) for pain, radiographic healing, health-related quality of life (Short-form-36, EuroQol-5D) and healthcare consumption. Cost-effectiveness ratios will be determined for both trial arms. Outcome will be monitored at regular intervals over the subsequent 24 months (1, 3 and 6 weeks, and 3, 6, 12, 18, and 24 months). Data will be analyzed on an intention to treat basis, using univariate and multivariable analyses.DiscussionThis trial will provide level-1 evidence on the effectiveness of the two mostly applied treatment options for three-or four part and split head proximal humeral fractures in the elderly. These data may support the development of a clinical guideline for treatment of these traumatic injuries.Trial registrationNetherlands Trial Register (NTR): NTR2040

【 授权许可】

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© Den Hartog et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.