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A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Western Orthopaedics Research and Education Foundation.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01726972
First Posted: November 15, 2012
Last Update Posted: November 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Western Orthopaedics Research and Education Foundation
  Purpose
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
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 ]
    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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726972


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

Responsible Party: Western Orthopaedics Research and Education Foundation
ClinicalTrials.gov Identifier: NCT01726972     History of Changes
Other Study ID Numbers: 369439-1
First Submitted: November 8, 2012
First Posted: November 15, 2012
Last Update Posted: November 15, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases