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This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.
It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | autogenous bone graft with the addition of OP-1 Putty |
|
| 2 | Active Comparator | autogenous bone graft alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of OP-1 Putty in Uninstrumented posterolateral fusion | Device | Use of OP-1 Putty in Uninstrumented posterolateral fusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone). | 6 weeks; 3, 6, 9, 12, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone). | 6 weeks; 3, 6, 9, 12, and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven | Connecticut | United States | ||||
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| Chicago |
| Illinois |
| United States |
| Royal Oak | Michigan | United States |
| Akron | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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