A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

Completed

• Conditions: Total Shoulder Arthroplasty; Glenohumeral Osteoarthritis

• Registration Number: NCT01726972
• Lead Sponsor: Western Orthopaedics Research and Education Foundation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-11
• Study Start: 2012-11
• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-15
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographic Loosening	2 years	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.