title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: St. George and Sutherland Hospitals, Grey St, Kogarah, NSW, Australia. gcssmith@icloud.com.|Sydney Orthopaedic Trauma and Reconstructive Surgery, 5/19 Kensington St, Kogarah, Sydney, NSW, 2217, Australia. gcssmith@icloud.com.
authors.forename: Geoffrey C S
authors.initials: GC
authors.lastname: Smith
authors.affiliation: Gosford District Hospital, Holden St, Gosford, NSW, Australia.
authors.forename: Ed
authors.initials: E
authors.lastname: Bateman
authors.affiliation: Royal North Shore Hospital, Reserve Rd, St. Leonards, NSW, Australia.
authors.forename: Ben
authors.initials: B
authors.lastname: Cass
authors.affiliation: The Canberra Hospital, 51 Jardine St, Kingston ACT, Australia.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Damiani
authors.affiliation: Prince of Wales Hospital, Barker St, Randwick, NSW, Australia.
authors.forename: Wade
authors.initials: W
authors.lastname: Harper
authors.affiliation: St. George and Sutherland Hospitals, Grey St, Kogarah, NSW, Australia.
authors.forename: Hugh
authors.initials: H
authors.lastname: Jones
authors.affiliation: Liverpool Hospital, Locked Bag 7103, Liverpool, NSW, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Lieu
authors.affiliation: Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, Australia.
authors.forename: Jeff
authors.initials: J
authors.lastname: Petchell
authors.affiliation: John Hunter Hospital, Lookout Rd, New Lambton Heights, NSW, Australia.
authors.forename: Minas
authors.initials: M
authors.lastname: Petrelis
authors.affiliation: Westmead Hospital, Hawkesbury Rd and Darcy Rd, Westmead, NSW, Australia.
authors.forename: Kalman
authors.initials: K
authors.lastname: Piper
authors.affiliation: Concord Hospital, Hospital Road, Concord, NSW, Australia.
authors.forename: Doron
authors.initials: D
authors.lastname: Sher
authors.affiliation: Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, Australia.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Smithers
authors.affiliation: Concord Hospital, Hospital Road, Concord, NSW, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Trantalis
authors.affiliation: The Canberra Hospital, 51 Jardine St, Kingston ACT, Australia.
authors.forename: Sindy
authors.initials: S
authors.lastname: Vrancic
authors.affiliation: Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Australia, Liverpool, NSW, Australia.
authors.forename: Ian A
authors.initials: IA
authors.lastname: Harris
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D000367:Age Factors; D000072228:Arthroplasty, Replacement, Shoulder / Q000009:adverse effects / Q000379:methods; D001315:Australia; D004185:Disability Evaluation; D006811:Humerus / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery; D010147:Pain Measurement; D020127:Recovery of Function; D012107:Research Design; D012784:Shoulder Fractures / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery; D020069:Shoulder Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: Arthroplasty; Fracture; Proximal humerus; Reverse shoulder arthroplasty; Surgery; Treatment