Overview

This trial is active, not recruiting.

Conditions total shoulder arthroplasty, glenohumeral osteoarthritis
Sponsor Western Orthopaedics Research and Education Foundation
Start date November 2012
End date February 2013
Trial size 150 participants
Trial identifier NCT01726972, 369439-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Measure
Radiographic Loosening
time frame: 2 years

Eligibility Criteria

Male or female participants from 21 years up to 90 years old.

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

Additional Information

Official title A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Western Orthopaedics Research and Education Foundation.