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This purpose of this study is to determine fusion rates and compare clinical outcomes of the NanoFUSE® Bioactive Matrix during post-market clinical use.
NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. This product provides a bone graft substitute that remodels into the recipient's skeletal system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoFUSE® PMCF | Other | NanoFUSE® Bioactive Matrix will be implanted according to labeling and the intended surgical treatment plan of the surgeon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoFUSE® Bioactive Matrix | Device | NanoFUSE® is placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Success that indicates patient achieving fused or probably fused status. | at 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall patient success | Overall patient success will be based on all clinical and radiographic evaluation | 12 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holly Cole | Contact | 978-358-7307 | 1004 | hollycole@rqmis.com |
| Ashley Lyons | Contact | 978-358-7307 | 1005 | ashleylyons@rqmis.com |
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