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| Name | Class |
|---|---|
| Flower Orthopedics | UNKNOWN |
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This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \and hardware complications.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flower Cube | Device | single use, sterile disposable fixation construct |
| Measure | Description | Time Frame |
|---|---|---|
| Union Rates | Confirm union rates comparable to existing outcomes complications with our proposed construct. | 12 months |
| Hardware Failures | Evaluate hardware failures with our proposed construct. | 12 months |
| Complications | Evaluate complications with the procedure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost Data | Review cost data using the Flower Orthopedics single use, sterile disposable fixation construct performed in an outpatient surgical setting compared to in patient hospital setting. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from the surgeons' private practices. These patients have already met the criteria for surgical intervention and have agreed to undergo the operative procedure and postoperative management.
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| Name | Affiliation | Role |
|---|---|---|
| John Levin, DPM | JEM Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JEM Research Institute | Atlantis | Florida | 33462 | United States |
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