Perioperative Complications in Reversed Shoulder Arthroplasties
- Conditions
- Proximal Humeral Fracture
- Registration Number
- NCT03243409
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 105
- Complex( 3- or 4-part) humerus fractures undergoing reversed shoulder arthroplasties.
- No exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures. 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. 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 Outcome Measures
Name Time Method Number of patients affected by minor complications after surgery, according to underlying disease First week after surgery Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.
Number of patients with cardiovascular diseases affected by minor complications after surgery 1 year after surgery Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.
Number of patients with cardiovascular diseases affected by major complications after surgery 1 year after surgery Underlying diseases group: cardiovascular, neurological, rheumatic, psychiatric, neoplasic.
Number of patients undergoing anticoagulant treatment with minor complications 90 days after surgery Previous acenocoumarol treatment
Number of patients undergoing anticoagulant treatment with major complications 90 days after surgery Previous acenocoumarol treatment
Number of patients undergoing antiplatelet treatment with minor complications 90 days after surgery Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel
Number of patients undergoing antiplatelet treatment with major complications 90 days after surgery Previous Acetylsalicylic acid (Aspirin), triflusal, ticlopidine, clopidogrel or prasugrel
Transfusion rates according to the preoperative ASA group 1 week after surgery Number of transfusion requirement.
Length of hospital stay according to the preoperative ASA group 1 week after surgery Length from the surgical intervention according to ASA risk
Trial Locations
- Locations (1)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain