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A Randomized, Subject-Assessor Blind, Multi-center, Comparative Clinical Trial to evaluate the efficacy and safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inject BMP | Experimental | ExcelOS Inject / rhBMP-2 |
|
| Locally Harvested Bone | Active Comparator | Locally Harvested Bone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inject BMP | Device |
| ||
| Locally Harvested Bone |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks) | at 48 weeks after surgery |
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Inclusion Criteria:
The subject needs the infusion between the first lumbar vertebrato and the first ilium from those who require posterior spinal instrumentation and interbody fusion for the following reasons,
Exclusion Criteria:
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