Perioperative Complications in Reversed Shoulder Arthroplasties

NCT ID: NCT03243409

Last Updated: 2017-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-25

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Proximal Humeral Fracture

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carles Torrens Canovas

Role: STUDY_DIRECTOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Laura Noguera Alonso

Role: CONTACT

+34660708399

Facility Contacts

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Laura Noguera, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25186842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23834993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17463122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23569688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24257664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22652065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23334846 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21879403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25066822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24418780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24246529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25086490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18054669 (View on PubMed)

Other Identifiers

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IIBSP-HUM-2017-51

Identifier Type: -

Identifier Source: org_study_id

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