A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01726972

Enrollment

Registered

2012-11-15

Start date

2012-11-30

Completion date

2015-04-30

Last updated

2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glenohumeral Osteoarthritis, Total Shoulder Arthroplasty

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results