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Clinical Trials/NCT03243409
NCT03243409
Unknown
Not Applicable

Perioperative Complications in Proximal Humeral Fractures Treated With Reversed Shoulder Arthroplasties

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country105 target enrollmentJuly 25, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proximal Humeral Fracture
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
105
Locations
1
Primary Endpoint
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 25, 2017
End Date
August 31, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • No exclusion criteria

Outcomes

Primary Outcomes

Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.

Time Frame: 1 year after surgery

Minor complications are medical complications, which usually don't affect to the functional outcome of arthroplasties

Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.

Time Frame: 1 year after surgery

Major complications are surgical complications( dislocation, periprosthetic fracture, infection) which usually affect to the functional outcome and can lead to a revision surgery

Secondary Outcomes

  • Number of patients affected by minor complications after surgery, according to underlying disease(First week after surgery)
  • Number of patients with cardiovascular diseases affected by minor complications after surgery(1 year after surgery)
  • Number of patients with cardiovascular diseases affected by major complications after surgery(1 year after surgery)
  • Number of patients undergoing anticoagulant treatment with minor complications(90 days after surgery)
  • Number of patients undergoing anticoagulant treatment with major complications(90 days after surgery)
  • Number of patients undergoing antiplatelet treatment with minor complications(90 days after surgery)
  • Number of patients undergoing antiplatelet treatment with major complications(90 days after surgery)
  • Transfusion rates according to the preoperative ASA group(1 week after surgery)
  • Length of hospital stay according to the preoperative ASA group(1 week after surgery)

Study Sites (1)

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