Clinical trial NCT03243409: Perioperative Complications in Reversed Shoulder Arthroplasties
Official title: Perioperative Complications in Proximal Humeral Fractures Treated With Reversed Shoulder Arthroplasties
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Proximal Humeral Fracture
Keywords: reversed shoulder arthroplasties
clinical complications
complex proximal humeral fractures
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 105
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing reversed shoulder arthroplasties owing to three or four parts fractures of the proximal humerus

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
timeFrame: First week after surgery
measure: Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
timeFrame: 90 days after surgery
measure: Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
timeFrame: 1 year after surgery
measure: Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
timeFrame: First week after surgery
measure: Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
timeFrame: 90 days after surgery
measure: Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Number of patients affected by minor complications after surgery, according to underlying disease
timeFrame: First week after surgery
measure: Number of patients with cardiovascular diseases affected by minor complications after surgery
timeFrame: 90 days after surgery
measure: Number of patients with cardiovascular diseases affected by minor complications after surgery
timeFrame: 1 year after surgery
measure: Number of patients with cardiovascular diseases affected by major complications after surgery
timeFrame: First week after surgery
measure: Number of patients with cardiovascular diseases affected by major complications after surgery
timeFrame: 90 days after surgery
measure: Number of patients with cardiovascular diseases affected by major complications after surgery
timeFrame: 1 year after surgery
measure: Number of patients undergoing anticoagulant treatment with minor complications
timeFrame: First week after surgery
measure: Number of patients undergoing anticoagulant treatment with major complications
timeFrame: First week after surgery
measure: Number of patients undergoing anticoagulant treatment with minor complications
timeFrame: 90 days after surgery
measure: Number of patients undergoing anticoagulant treatment with major complications
timeFrame: 90 days after surgery
measure: Number of patients undergoing antiplatelet treatment with minor complications
timeFrame: First week after surgery
measure: Number of patients undergoing antiplatelet treatment with major complications
timeFrame: First week after surgery
measure: Number of patients undergoing antiplatelet treatment with minor complications
timeFrame: 90 days after surgery
measure: Number of patients undergoing antiplatelet treatment with major complications
timeFrame: 90 days after surgery
measure: Transfusion rates according to the preoperative ASA group
timeFrame: 1 week after surgery
measure: Length of hospital stay according to the preoperative ASA group
timeFrame: 1 week after surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Carles Torrens Canovas
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.