Total Shoulder Arthroplasty Clinical Trial
Official title:
A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty
| NCT number | NCT01726972 |
| Other study ID # | 369439-1 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2012 |
| Est. completion date | April 2015 |
| Verified date | November 2012 |
| Source | Western Orthopaedics Research and Education Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 41 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 90 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Western Orthopaedics Research and Education Foundation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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