Abstract
BackgroundProximal humeral fractures are common in older patients. The majority are minimally displaced and are associated with good outcomes after nonoperative treatment. Poorer outcomes are associated with displaced, multipart fractures. There is no clear benefit from surgical fracture fixation compared to nonoperative treatment. Replacement of the fractured humeral head with a hemiarthroplasty is another treatment option, but has not been shown to be clearly superior to nonoperative treatment or internal fixation. Recently, reverse total shoulder arthroplasty has been used to treat these fractures, particularly in the older population with several case series demonstrating good outcomes. No comparative trial has been performed to test the effectiveness of reverse total shoulder arthroplasty against nonoperative treatment.Methods/designReShAPE (Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly) is a multicenter combined randomized and observational study. The primary objective is to compare pain and function 12 months post fracture using the American Shoulder and Elbow Society (ASES) score in patients aged 70 years or older with three- and four-part proximal humeral fractures treated by either reverse shoulder arthroplasty or nonoperative treatment. Secondary outcome measures will include the DASH (Disability of the Arm, Shoulder and Hand) score, the EQ-5D (EuroQol Health Survey), the EQ-VAS, pain, radiological parameters and complications.DiscussionThe study will assess the effectiveness of reverse shoulder arthroplasty for complex proximal humeral fractures and thereby guide treatment of a common injury in the older population.Trial registrationWorld Health Organization Universal Trial Number (WHO UTN): U1111-1180-5452. Registered on 10 March 2016.Australian and New Zealand Clinical Trials Registry (ANZCTR): 12616000345482. Registered on 16 March 2016.
Highlights
Proximal humeral fractures are common in older patients
The study will assess the effectiveness of reverse shoulder arthroplasty for complex proximal humeral fractures and thereby guide treatment of a common injury in the older population
Humeral neck fractures account for 5% of fractures of the appendicular skeleton [1] and are the third commonest osteoporotic fracture [2] occurring with an incidence of 6.6 per 1000 person years [3]
Summary
Proximal humeral fractures are common in older patients. The majority are minimally displaced and are associated with good outcomes after nonoperative treatment. Replacement of the fractured humeral head with a hemiarthroplasty is another treatment option, but has not been shown to be clearly superior to nonoperative treatment or internal fixation. Reverse total shoulder arthroplasty has been used to treat these fractures, in the older population with several case series demonstrating good outcomes. There is a unipolar age distribution with most occurring in the older independent population with osteoporosis who fall from a standing height [4] This incidence is set to increase in the 20 years as a result of population growth and an aging population [5]. Replacement of the fractured humeral head (hemiarthroplasty) is another treatment option, but has not been shown to be clearly superior to nonoperative treatment or plate fixation [14, 15]
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