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The purpose of this study is to obtain post market performance and safety data of the Ellipse PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.
Subject data will be reviewed at the following visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRECICE System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRECICE System | Device | Lenthening of either the tibia or femur with the PRECICE System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distraction Control: actual distraction rate vs. target distraction rate | Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Union | Following completion of the subject's distraction regimen, every 4-6 weeks until the subject's treated limb is evaluated as consolidated, an expected average of 66 days | |
| Pain | Pain measured by the SF-36v2, American Academy of Orthopaedic Surgeons Lower Limb Outcomes Questionnaire, and medication use. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart A Green, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States | ||
| Nemours Children's Hospital |
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| Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months |
| Healing Index | The total treatment period with the PRECICE System in situ, divided by the length of bone growth in centimeters. | Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months |
| Number of days to complete lengthening | Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days |
| Number of days to complete full weight bearing | Up to an expected average of 99 days. |
| Number of days to full consolidation | Following completion of the subject's distraction regimen, every 4-6 weeks until the subject's treated limb is evaluated as consolidated, an expected average of 66 days |
| Adverse Events | Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months |
| Device-related complications | Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months |
| Procedure-related complications | Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months |
| Orlando |
| Florida |
| 32827 |
| United States |
| Paley Advanced Limb Lengthening Institute | West Palm Beach | Florida | 33407 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |