A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Primary Endpoint
- Radiographic Loosening
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 21 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Radiographic Loosening
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported