Effectiveness of straight arm traction versus operative treatment for displaced paediatric supracondylar humerus fractures: a randomised single-blind controlled, a non-inferiority trial-the STOPUS trial.
Mengistu Gebreyohanes Mengesha, Ephrem Gebrehana Adem, Claude F Martin, William J Harrison
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引用次数: 0
Abstract
Background: Supracondylar humeral fractures are common injuries in children and can be associated with high morbidity and lead to lifelong disability. The method of treatment affects the risk of complications and potentially the functional outcome. Closed reduction and percutaneous pinning CRPP has become the most widely used treatment method in high-income countries. In the current literature, both CRPP and lateral straight arm traction have been shown to give good results and reasonable levels of complications. The two methods have never been tested against each other in a randomised trial. Furthermore, these methods have not been analysed prospectively in the low and middle income context.
Methods: The study will be a prospective randomised trial comparing lateral straight arm traction LSAT against CRPP. Recruitment will be at 8 large referral hospitals in Ethiopia. Based on non-inferiority power calculation, we plan to recruit 220 patients. The principal outcome measure will be the PROMIS parent proxy upper extremity short form 8a score version 3.0 at 12 months. The secondary outcome measures will be the Flynn's criteria; complications; PROMIS parent proxy upper extremity short form 8a score version 3.0 at 6 months; PROMIS parent proxy global health 7 + 2 score version 3.0 administered at 6 and 12 months; and economic analysis of hospital costs for the two treatment modalities.
Discussion: Supracondylar humeral fractures are common and serious injuries which occur frequently in LMICs where often half the population are under 18 years of age. Such countries have limited capacity for fracture care. Finding solutions which may avoid referral and operative intervention is paramount in developing access to timely and affordable care for all people. If LSAT is non-inferior to CRPP, then children can be treated locally in a cost-effective manner with avoidance of disability.
Trial registration: ISRCTN Ref 62164933. Registered on 25 July 2024.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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