A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Western Orthopaedics Research and Education Foundation
ClinicalTrials.gov Identifier:
NCT01726972
First received: November 8, 2012
Last updated: November 14, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


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)
  Eligibility

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726972

Locations
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
ClinicalTrials.gov 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

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

ClinicalTrials.gov processed this record on July 22, 2014