A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis: the HUmeral Shaft Fracture FIXation (HU-FIX) Study protocol

Abstract

Background Humeral shaft fractures constitute around 1% of adult fractures in the UK, with an annual incidence of approximately 13 per 100,000 population. Historically, these injuries have been primarily managed non-operatively, with operative fixation reserved for specific indications. Although some recent retrospective studies have suggested there are potential benefits of operative fixation over humeral bracing, there is a deficiency in level 1 evidence to support operative management as the primary treatment for humeral shaft fractures. Methods/design This single-centre prospective randomised controlled trial aims to recruit 70 adult patients with an isolated closed fracture of the humeral diaphysis into one of two treatment arms: operative ( n = 35) or non-operative ( n = 35). The operative arm will undergo open reduction and internal fixation (ORIF) of the fracture using a standard fixation technique (plate and screws). The non-operative arm will be fitted with a prefabricated humeral brace until fracture union. All patients will be followed up for 1 year post-intervention. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at 3 months post-intervention. Secondary outcome measures will include pain, treatment complications, return to work or sporting activities, shoulder and elbow range of motion, radiographic assessment, EuroQol (EQ-5D) Health Outcome score and 12-item Short Form (SF-12) Health Survey score. A health economic analysis will be performed to compare the cost implications of each treatment strategy. Discussion This randomised controlled trial will provide level 1 evidence comparing a standard ORIF technique against functional bracing for isolated closed humeral shaft fractures. The investigators hope that the study results will assist surgeons in their decision-making when managing patients with these injuries. Trial registration ClinicalTrials.gov, NCT03689335 . Registered on 28 September 2018 (retrospectively). Electronic supplementary material The online version of this article (10.1186/s13063-019-3576-0) contains supplementary material, which is available to authorized users.

Can We Stratify Quality and Cost for Older Patients With Proximal and Midshaft Humerus Fractures?

“…have not yet been reported. 50 In the analysis of our entire cohort, room/board was the largest monetary contributor to inpatient care, comprising over 45% of the total index admission cost. This finding corroborates other studies that have described the main contributing factors to inpatient cost for middle-aged and geriatric patients with orthopedic trauma.…”

“…Although one group is conducting a single-center prospective randomized controlled trial to evaluate these parameters, their results have not yet been reported. 50 …”

Treatment of Midshaft Humerus Fractures Using Early Functional Bracing: Results and Prognostic Factors

“…These include poor follow up rates, leading to amplification of proportions of non-union patients, who will present back to follow up more reliably than healed unions [ 9 - 11 ]. In addition, differences in protocols of applying a humeral brace across different countries and institutions have been observed in many studies, such as the use of U-slab, hanging cast, or backslab initially (and for different periods of time) before brace application, all of which could affect final outcomes [ 8 , 12 , 13 ]. In the literature, the reported time to union varies 8 to 30 weeks with an average of 10.7 weeks [ 1 , 2 , 12 , 14 , 15 ].…”

Quotation errors related to the Distal Radius Acute Fracture Fixation Trial paper

“…'Given the varied practice in ankle fracture surgery including implant selection for fibular stabilisation, medial malleolar fracture fixation, wound closure, post-operative immobilisation and weight-bearing restrictions, the study has a pragmatic design to reproduce dayto-day trauma care' (Carter et al, 2019) 'The mean PRWE score after open reduction and volar locking plate fixation after one year of follow-up in patients aged over 18 years with a dorsally displaced distal radius fracture is 15 with a standard deviation of 17' (Mulders et al, 2016) 'The study [HU-FIX] is pragmatic and allows for normal variations in clinical practice, including in the surgical approach and fixation method used during ORIF, as well as the involvement of physiotherapy. The investigators hope that this pragmatic design will reproduce day-to-day trauma care and improve the external validity of study results' (Oliver et al, 2019) 'These figures have been used recently in other cost evaluation studies' (Tissingh et al, 2017) 'The procedures for Kirschner wire (K-wire) internal fixation were performed according to the method described in previous studies' (Wan et al, 2018)…”