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Product is no longer being manufactured and marketed.
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The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a retrospective, multi-center, single-arm study intended to collect data on the survivorship and long-term safety and effectiveness of the device.
This active surveillance study is intended to evaluate the survivorship and long-term safety and effectiveness of the Stelkast Surpass Acetabular System. Neither the patient nor the surgeon are blinded to treatment. The study will compare the Surpass' survivorship to the survivorship observed in a historical control group established by a meta-analysis. The evaluation will be conducted for a period of ten years. These evaluations will be recorded through onsite visits and/or mailings sent to physicians requesting deidentified patient-level data for subjects implanted with the Surpass system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stelkast Surpass Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stelkast Surpass Acetabular System implant | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | 10 Years |
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Inclusion Criteria:
Exclusion Criteria:
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All patients treated with the Stelkast Surpass Acetabular System at the participating siteswill be included in the evaluation.
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| Name | Affiliation | Role |
|---|---|---|
| Abigail Allen | MCRA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gill Orthopedic Clinic | Charlotte | North Carolina | 28207 | United States | ||
| Mutschler Orthopedic Institute |
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| Canonsburg |
| Pennsylvania |
| 15317 |
| United States |
| Premier Orthopedics and SPM Associates | Glen Mills | Pennsylvania | 19342 | United States |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |