A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty
1 other identifier
observational
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 8, 2012
CompletedFirst Posted
Study publicly available on registry
November 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedOctober 23, 2020
November 1, 2012
2.4 years
November 8, 2012
October 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Radiographic Loosening
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.
2 years
Eligibility Criteria
Patients who have previously undergone anatomic total shoulder arthroplasty for the treatment of glenohumeral osteoarthritis.
You may qualify if:
- 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
You may not qualify if:
- Patients less than 21 years of age
- Patients who have been imprisoned since the time of surgery
- Patients who are mentally impaired
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Denver, Colorado, 80218, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2012
First Posted
November 15, 2012
Study Start
November 1, 2012
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
October 23, 2020
Record last verified: 2012-11