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. 2017 Feb 28;18(1):91.
doi: 10.1186/s13063-017-1826-6.

Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly (ReShAPE trial) : study protocol for a multicentre combined randomised controlled and observational trial

Geoffrey C S Smith  1   2 , Ed Bateman  3 , Ben Cass  4 , Maurizio Damiani  5 , Wade Harper  6 , Hugh Jones  7 , David Lieu  8 , Jeff Petchell  9 , Minas Petrelis  10 , Kalman Piper  11 , Doron Sher  12 , Christopher J Smithers  9 , John Trantalis  12 , Sindy Vrancic  5 , Ian A Harris  13
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Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly (ReShAPE trial) : study protocol for a multicentre combined randomised controlled and observational trial

Geoffrey C S Smith et al. Trials. .

Abstract

Background: Proximal 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/design: ReShAPE (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.

Discussion: 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.

Trial registration: World 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.

Keywords: Arthroplasty; Fracture; Proximal humerus; Reverse shoulder arthroplasty; Surgery; Treatment.

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Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) flowchart
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Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram
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