A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

Western Orthopaedics Research and Education Foundation41 enrolled

Overview

The proposed study aims to objectively assess 2-year clinical and radiographic results for the rate of glenoid component loosening in total shoulder arthroplasty (TSA). This retrospective radiographic review will provide evidence for equivalence or superiority in curtailing loosening, a known complication in arthroplasty, when a hemostatic agent is utilized in conjunction with cement at the glenoid.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Total Shoulder Arthroplasty Glenohumeral Osteoarthritis

Eligibility

Sex: ALLMin age: 21 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must have completed at least 2 years follow-up following their total shoulder replacement * Patients must have had radiographic imaging obtained at that 2 years Exclusion Criteria: * Patients less than 21 years of age * Patients who have been imprisoned since the time of surgery * Patients who are mentally impaired

Locations (1)

Unnamed facility

Denver, Colorado, United States

Outcomes

Primary Outcomes

Radiographic Loosening

Radiographic loosening is defined by the presence of radiolucent lines at the bone-cement interface at 2 years. Lines are measured as being either not-present, less than 2mm or greater than/equal to 2mm, in addition to implant seating and the radiodensity between the flanges of the central peg.

Time frame: 2 years

Data from ClinicalTrials.gov

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