Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on sleep in brain health

LIVE: Thursday 2nd May 2024, 18:00-19:30 (CEST)

Quality sleep is essential for health. But what happens to our brains when sleep patterns are disturbed? Join our experts to explore the interplay between sleep disruption and neurological diseases, and the questions that you need to be asking your patients to help you prevent the harmful effects of sleep deprivation.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Geoffrey C. S. Smith, Ed Bateman, Ben Cass, Maurizio Damiani, Wade Harper, Hugh Jones, David Lieu, Jeff Petchell, Minas Petrelis, Kalman Piper, Doron Sher, Christopher J. Smithers, John Trantalis, Sindy Vrancic, Ian A. Harris

Published in: Trials | Issue 1/2017

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
2.
Calvo E, Morcillo D, Foruria AM, Redondo-Santamaria E, Osorio-Picorne F, Caeiro JR. Nondisplaced proximal humeral fractures: high incidence among outpatient-treated osteoporotic fractures and severe impact on upper extremity function and patient subjective health perception. J Shoulder Elb Surg. 2011;20(5):795–801.CrossRef
3.
Lanting B, MacDermid J, Drosdowech D, Faber KJ. Proximal humeral fractures: a systematic review of treatment modalities. J Shoulder Elb Surg. 2008;17(1):42–54.CrossRef
4.
Court-Brown CM, Garg A, McQueen MM. The epidemiology of proximal humeral fractures. Acta Orthop Scand. 2001;72(4):365–71.CrossRefPubMed
5.
Kannus P, Palvanen M, Niemi S, Parkkari J, Jarvinen M, Vuori I. Osteoporotic fractures of the proximal humerus in elderly Finnish persons: sharp increase in 1970–1998 and alarming projections for the new millennium. Acta Orthop Scand. 2000;71(5):465–70.CrossRefPubMed
6.
Neer 2nd CS. Displaced proximal humeral fractures. I. Classification and evaluation. J Bone Joint Surg Am. 1970;52(6):1077–89.CrossRefPubMed
7.
Gaebler C, McQueen MM, Court-Brown CM. Minimally displaced proximal humeral fractures: epidemiology and outcome in 507 cases. Acta Orthop Scand. 2003;74(5):580–5.CrossRefPubMed
8.
Nho SJ. Management of proximal humeral fractures based on current literature. J Bone Joint Surg Am. 2007;89 Suppl 3:44.PubMed
9.
Murray IR, Amin AK, White TO, Robinson CM. Proximal humeral fractures: current concepts in classification, treatment and outcomes. J Bone Joint Surg (Br). 2011;93(1):1–11.CrossRef
10.
Olerud P, Ahrengart L, Ponzer S, Saving J, Tidermark J. Internal fixation versus nonoperative treatment of displaced 3-part proximal humeral fractures in elderly patients: a randomized controlled trial. J Shoulder Elb Surg. 2011;20(5):747–55.CrossRef
11.
Fjalestad T, Hole MO, Hovden IAH, Blucher J, Stromsoe K. Surgical treatment with an angular stable plate for complex displaced proximal humeral fractures in elderly patients: a randomized controlled trial. J Orthop Trauma. 2012;26(2):98–106.CrossRefPubMed
12.
13.
Sanders RJ, Thissen LG, Teepen JC, van Kampen A, Jaarsma RL. Locking plate versus nonsurgical treatment for proximal humeral fractures: better midterm outcome with nonsurgical treatment. J Shoulder Elb Surg. 2011;20(7):1118–24.CrossRef
14.
Boons HW, Goosen JH, van Grinsven S, van Susante JL, van Loon CJ. Hemiarthroplasty for humeral four-part fractures for patients 65 years and older: a randomized controlled trial. Clin Orthop Relat Res. 2012;470(12):3483–91.CrossRefPubMedPubMedCentral
15.
Olerud P, Ahrengart L, Ponzer S, Saving J, Tidermark J. Hemiarthroplasty versus nonoperative treatment of displaced 4-part proximal humeral fractures in elderly patients: a randomized controlled trial. J Shoulder Elb Surg. 2011;20(7):1025–33.CrossRef
16.
Ross M, Hope B, Stokes A, Peters SE, McLeod I, Duke PFR. Reverse shoulder arthroplasty for the treatment of three-part and four-part proximal humeral fractures in the elderly. J Shoulder Elbow Surg. 2015;24(2):215–22. doi: 10.​1016/​j.​jse.​2014.​05.​022. Epub 2014 Aug 29.
17.
Lenarz C, Shishani Y, McCrum C, Nowinski RJ, Edwards TB, Gobezie R. Is reverse shoulder arthroplasty appropriate for the treatment of fractures in the older patient?: early observations. Clin Orthop Relat Res. 2011;469(12):3324–31.CrossRefPubMedPubMedCentral
18.
Cazeneuve J-F, Cristofari D-J. The reverse shoulder prosthesis in the treatment of fractures of the proximal humerus in the elderly. J Bone Joint Surg (Br). 2010;92(4):535–9.CrossRef
19.
Cazeneuve J-F, Cristofari D-J. Long term functional outcome following reverse shoulder arthroplasty in the elderly. Orthop Traumatol Surg Res. 2011;97(6):583–9.CrossRefPubMed
20.
Bufquin T, Hersan A, Hubert L, Massin P. Reverse shoulder arthroplasty for the treatment of three- and four-part fractures of the proximal humerus in the elderly: a prospective review of 43 cases with a short-term follow-up. J Bone Joint Surg (Br). 2007;89(4):516–20.CrossRef
21.
Cuff D. Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. J Bone Joint Surg Am. 2012;94(21):1996.CrossRefPubMed
22.
Gallinet D, Clappaz P, Garbuio P, Tropet Y, Obert L. Three or four parts complex proximal humerus fractures: hemiarthroplasty versus reverse prosthesis: a comparative study of 40 cases. Orthop Traumatol Surg Res. 2009;95(1):48–55.CrossRefPubMed
23.
Acevedo DC, Vanbeek C, Lazarus MD, Williams GR, Abboud JA. Reverse shoulder arthroplasty for proximal humeral fractures: update on indications, technique, and results. J Shoulder Elb Surg. 2014;23(2):279–89.CrossRef
24.
Cheung E, Willis M, Walker M, Clark R, Frankle MA. Complications in reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2011;19(7):439–49.CrossRefPubMed
25.
26.
Callahan CM, Unverzagt FW, Hui SL, Parsons AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. 2002;40(9):771–81.
27.
Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, et al. A standardized method for the assessment of shoulder function. J Shoulder Elb Surg. 1994;3(6):347–52.CrossRef
28.
Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elb Surg. 2002;11(6):587–94.CrossRef
29.
Roy J-S, MacDermid JC, Woodhouse LJ. Measuring shoulder function: a systematic review of four questionnaires. Arthritis Rheum. 2009;61(5):623–32.CrossRefPubMed
30.
Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996;29(6):602–8.CrossRefPubMed
31.
Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Mole D. Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral osteoarthritis with massive rupture of the cuff. Results of a multicentre study of 80 shoulders. J Bone Joint Surg (Br). 2004;86(3):388–95.CrossRef
32.
Tashjian RZ. Minimal clinically important differences in ASES and Simple Shoulder Test Scores after nonoperative treatment of rotator cuff disease. J Bone Joint Surg Am. 2010;92(2):296.CrossRefPubMed
33.
Mata-Fink A, Meinke M, Jones C, Kim B, Bell J-E. Reverse shoulder arthroplasty for treatment of proximal humeral fractures in older adults: a systematic review. J Shoulder Elb Surg. 2013;22(12):1737–48.CrossRef
Metadata
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
Authors
Geoffrey C. S. Smith
Ed Bateman
Ben Cass
Maurizio Damiani
Wade Harper
Hugh Jones
David Lieu
Jeff Petchell
Minas Petrelis
Kalman Piper
Doron Sher
Christopher J. Smithers
John Trantalis
Sindy Vrancic
Ian A. Harris
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1826-6

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Research

Exploring patients’ treatment journeys following randomisation in mental health trials to improve future trial conduct: a synthesis of multiple qualitative data sets

Study protocol

The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial

Correction

Correction to: Concomitant, sequential, and 7-day triple therapy in first-line treatment of Helicobacter pylori infection in Korea: study protocol for a randomized controlled trial

Study protocol

Impact of improved recording of work-relatedness in primary care visits at occupational health services on sickness absences: study protocol for a randomised controlled trial

Study protocol

Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial)

Study protocol

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial