A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

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.

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Key information

Conditions

Total Shoulder Arthroplasty Glenohumeral Osteoarthritis

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Denver, Colorado, 80218, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Western Orthopaedics Research and Education Foundation

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Nov 15, 2012
Registry last updated: Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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