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This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal fusion.
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 created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine. This product provides a bone graft substitute that remodels into the recipient's skeletal system. Radiographic success will be the primary judgement of success. All patient's achieving fused or probably fused status will be judged as a success.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoFuse® PL Gutter | Other | NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) | Device | NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Success | All patients achieving fused or probably fused status will be judged as successes at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall patient success | Overall patient success will be based on all clinical and radiographic evaluation parameters and complications for the indication for use. Success criteria includes the following:
|
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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 |
| John McGuire | Contact | 978-358-7307 | 1003 | johnmcguire@rqmis.com |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 12 months postoperatively |