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A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

Sponsor
Western Orthopaedics Research and Education Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT01726972
Collaborator
(none)
41
Enrollment
1
Location
28.9
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    41 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty
    Study Start Date :
    Nov 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2015
    Actual Study Completion Date :
    Apr 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 90 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Denver Colorado United States 80218

    Sponsors and Collaborators

    • Western Orthopaedics Research and Education Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Western Orthopaedics Research and Education Foundation
    ClinicalTrials.gov Identifier:
    NCT01726972
    Other Study ID Numbers:
    • 369439-1
    First Posted:
    Nov 15, 2012
    Last Update Posted:
    Oct 23, 2020
    Last Verified:
    Nov 1, 2012
    Additional relevant MeSH terms:
    Osteoarthritis

    Study Results

    No Results Posted as of Oct 23, 2020