Perioperative Complications in Reversed Shoulder Arthroplasties

Perioperative Complications in Proximal Humeral Fractures Treated With Reversed Shoulder Arthroplasties

Retrospective observational study of reversed shoulder arthroplasties by proximal humeral fracture. Analysis of preoperative risk factors as well as minor and major complications at the first week, 90 days and 1 year.

Study Overview

• Status: Unknown
• Conditions: Proximal Humeral Fracture

Detailed Description

The study is a multicenter retrospective observational study (3 centers). Data are collected from 105 patients over 65 years-old undergoing reversed shoulder arthroplasties by proximal humerus fractures, in 3 or 4 parts.

Patient information is obtained from the clinical records in their usual preoperative assessment, and follow-up on the usual routine checks, at the first week, 90 days and 1 year.

Minor and major complications rates are evaluated according to preoperative risk (ASA), underlying diseases and according to anticoagulant / antiaggregant treatments.

Likewise, transfusion rates related to ASA, as well as length of hospital stay related to it.

• Study Type: Observational
• Enrollment (Anticipated): 105

Contacts and Locations

• Study Contact: Name: Laura Noguera Alonso; Phone Number: +34660708399; Email: lnoguera@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital de La Santa Creu I Sant Pau
    • Contact: Laura Noguera, MD; Email: lnoguera@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing reversed shoulder arthroplasties owing to three or four parts fractures of the proximal humerus

Description

Inclusion Criteria:

• Complex( 3- or 4-part) humerus fractures undergoing reversed shoulder arthroplasties.

Exclusion Criteria:

• No exclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.	Minor complications are medical complications, which usually don't affect to the functional outcome of arthroplasties	First week after surgery
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.	Minor complications are medical complications, which usually don't affect to the functional outcome of arthroplasties	90 days after surgery
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.	Minor complications are medical complications, which usually don't affect to the functional outcome of arthroplasties	1 year after surgery
Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.	Major complications are surgical complications( dislocation, periprosthetic fracture, infection) which usually affect to the functional outcome and can lead to a revision surgery	First week after surgery
Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.	Major complications are surgical complications( dislocation, periprosthetic fracture, infection) which usually affect to the functional outcome and can lead to a revision surgery	90 days after surgery
Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.	Major complications are surgical complications( dislocation, periprosthetic fracture, infection) which usually affect to the functional outcome and can lead to a revision surgery	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients affected by minor complications after surgery, according to underlying disease	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	First week after surgery
Number of patients with cardiovascular diseases affected by minor complications after surgery	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	90 days after surgery
Number of patients with cardiovascular diseases affected by minor complications after surgery	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	1 year after surgery
Number of patients with cardiovascular diseases affected by major complications after surgery	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	First week after surgery
Number of patients with cardiovascular diseases affected by major complications after surgery	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	90 days after surgery
Number of patients with cardiovascular diseases affected by major complications after surgery	Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.	1 year after surgery
Number of patients undergoing anticoagulant treatment with minor complications	Previous acenocoumarol treatment	First week after surgery
Number of patients undergoing anticoagulant treatment with major complications	Previous acenocoumarol treatment	First week after surgery
Number of patients undergoing anticoagulant treatment with minor complications	Previous acenocoumarol treatment	90 days after surgery
Number of patients undergoing anticoagulant treatment with major complications	Previous acenocoumarol treatment	90 days after surgery
Number of patients undergoing antiplatelet treatment with minor complications	Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel	First week after surgery
Number of patients undergoing antiplatelet treatment with major complications	Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel	First week after surgery
Number of patients undergoing antiplatelet treatment with minor complications	Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel	90 days after surgery
Number of patients undergoing antiplatelet treatment with major complications	Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel	90 days after surgery
Transfusion rates according to the preoperative ASA group	Number of transfusion requirement.	1 week after surgery
Length of hospital stay according to the preoperative ASA group	Length from the surgical intervention according to ASA risk	1 week after surgery

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Study Director: Carles Torrens Canovas, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

General Publications

• Ferrel JR, Trinh TQ, Fischer RA. Reverse total shoulder arthroplasty versus hemiarthroplasty for proximal humeral fractures: a systematic review. J Orthop Trauma. 2015 Jan;29(1):60-8. doi: 10.1097/BOT.0000000000000224.
• Boileau P, Winter M, Cikes A, Han Y, Carles M, Walch G, Schwartz DG. Can surgeons predict what makes a good hemiarthroplasty for fracture? J Shoulder Elbow Surg. 2013 Nov;22(11):1495-506. doi: 10.1016/j.jse.2013.04.018. Epub 2013 Jul 5.
• 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 Apr;89(4):516-20. doi: 10.1302/0301-620X.89B4.18435.
• Stanbury SJ, Voloshin I. Reverse shoulder arthroplasty for acute proximal humeral fractures in the geriatric patient: a review of the literature. Geriatr Orthop Surg Rehabil. 2011 Sep;2(5-6):181-6. doi: 10.1177/2151458511420140.
• Cuff DJ, Pupello DR. Comparison of hemiarthroplasty and reverse shoulder arthroplasty for the treatment of proximal humeral fractures in elderly patients. J Bone Joint Surg Am. 2013 Nov 20;95(22):2050-5. doi: 10.2106/JBJS.L.01637.
• Boyle MJ, Youn SM, Frampton CM, Ball CM. Functional outcomes of reverse shoulder arthroplasty compared with hemiarthroplasty for acute proximal humeral fractures. J Shoulder Elbow Surg. 2013 Jan;22(1):32-7. doi: 10.1016/j.jse.2012.03.006. Epub 2012 May 29.
• Jones KJ, Dines DM, Gulotta L, Dines JS. Management of proximal humerus fractures utilizing reverse total shoulder arthroplasty. Curr Rev Musculoskelet Med. 2013 Mar;6(1):63-70. doi: 10.1007/s12178-013-9155-1.
• 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 Dec;469(12):3324-31. doi: 10.1007/s11999-011-2055-z.
• Chalmers PN, Slikker W 3rd, Mall NA, Gupta AK, Rahman Z, Enriquez D, Nicholson GP. Author reply: reverse total shoulder for acute proximal humeral fracture: comparison to open reduction-internal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014 Sep;23(9):e222. doi: 10.1016/j.jse.2014.05.014. Epub 2014 Jul 24. No abstract available.
• 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 Elbow Surg. 2014 Feb;23(2):279-89. doi: 10.1016/j.jse.2013.10.003.
• Mata-Fink A, Meinke M, Jones C, Kim B, Bell JE. Reverse shoulder arthroplasty for treatment of proximal humeral fractures in older adults: a systematic review. J Shoulder Elbow Surg. 2013 Dec;22(12):1737-48. doi: 10.1016/j.jse.2013.08.021.
• Sebastia-Forcada E, Cebrian-Gomez R, Lizaur-Utrilla A, Gil-Guillen V. Reverse shoulder arthroplasty versus hemiarthroplasty for acute proximal humeral fractures. A blinded, randomized, controlled, prospective study. J Shoulder Elbow Surg. 2014 Oct;23(10):1419-26. doi: 10.1016/j.jse.2014.06.035. Epub 2014 Jul 30.
• Wall B, Walch G. Reverse shoulder arthroplasty for the treatment of proximal humeral fractures. Hand Clin. 2007 Nov;23(4):425-30, v-vi. doi: 10.1016/j.hcl.2007.08.002.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Anticipated): August 31, 2017
• Study Completion (Anticipated): August 31, 2017

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: reversed shoulder arthroplasties; clinical complications; complex proximal humeral fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: IIBSP-HUM-2017-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No