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The purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IlluminOss device | Experimental | IlluminOss bone-pin device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IlluminOss device | Device | The IlluminOssâ„¢ Bone Stabilization System is designed to deliver the device to the fracture site via the medullary canal of the bone using percutaneous techniques. Once the device is in place and has spanned the fracture site, the device is expanded and hardened to reduce and stabilize the fracture, to aid in the support and healing of the bone fracture by primary callous formation and remodeling. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location. | Immediately post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Fracture Union | 180 day | |
| Rate of Anatomic Alignment | 180 Day | |
| Functionality Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Trabajador | Santiago | Chile |
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|
| 180 Day |
| Grip Strength | 180 Day |
| Range of Motion | 180 day |
| Incidence of Reintervention of Target Fracture | 180 Day |
| Bone Pin Migration | 180 Day |
| Adverse Event Rate | 180 day |