Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Western Orthopaedics Research and Education Foundation.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Western Orthopaedics Research and Education Foundation Identifier:
First received: November 8, 2012
Last updated: November 14, 2012
Last verified: November 2012

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.

Total Shoulder Arthroplasty
Glenohumeral Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

Further study details as provided by Western Orthopaedics Research and Education Foundation:

Primary Outcome Measures:
  • Radiographic Loosening [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 150
Study Start Date: November 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who have previously undergone anatomic total shoulder arthroplasty for the treatment of glenohumeral osteoarthritis.


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
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Please refer to this study by its identifier: NCT01726972

United States, Colorado
Denver, Colorado, United States, 80218
Sponsors and Collaborators
Western Orthopaedics Research and Education Foundation
  More Information

No publications provided

Responsible Party: Western Orthopaedics Research and Education Foundation Identifier: NCT01726972     History of Changes
Other Study ID Numbers: 369439-1
Study First Received: November 8, 2012
Last Updated: November 14, 2012
Health Authority: United States: HCA-HealthONE IRB
United States: Food and Drug Administration processed this record on March 03, 2015