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This study is designed to evaluate the feasibility of recombinant human bone morphogenetic protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGEĀ® ) for anterior lumbar interbody fusion in patients with degenerative disc disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhBMP-2/ACS | Experimental |
| |
| Autograft | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhBMP-2/ACS/LT-CAGEĀ® Device | Device | rhBMP-2/ACS inserted into Sofamor Danek's LT-CAGEĀ® device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fusion | 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment (Oswestry Disability Index, ODI) | 24 month | |
| Neurological Status Assessment | 24 month | |
| Health status assessment (SF-36) |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Autograft/LT-CAGEĀ® Device | Device | LT-CAGEĀ® device filled with autogenous bone taken from the patient's iliac crest |
|
|
| 24 month |