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Parent sponsor company (Baxter Healthcare) company cut funding
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| Name | Class |
|---|---|
| Apatech, Inc. | INDUSTRY |
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A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Fusion | Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone graft substitute, autograft or allograft | Device | spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of successful radiographic fusion | 6 months, 12 months & 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance or improvement in neurological status, as compared to baseline scores | 6 months 12 months & 24 months | |
| Improvement of pain/function in comparison to pre-operative QOL scores | 6 months, 12 months & 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients enrolled in this study will be identified from the surgeon's medical practice and will include patients who failed conservative care and have been identified as requiring spinal fusion surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Huub Kreuwel, Ph.D | Director of Medical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94143 | United States | ||
| St. Joseph's Hospital - Resurgeons Orthopedics |
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|
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Carrollton Orthopedics | Carrollton | Georgia | 30117 | United States |
| Bluegrass Orthopedics & Hand Care Research | Lexington | Kentucky | 40509 | United States |
| Arthritis & Joint Center - U. Mass. Memorial | Worcester | Massachusetts | 01605 | United States |
| PRESSD | Southfield | Michigan | 48072 | United States |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | United States |
| Montana Neuroscience Institute Foundation | Missoula | Montana | 59802 | United States |
| Physicians Research Options Spine Center | Las Vegas | Nevada | 89144 | United States |
| Syracuse Orthopedic Specialists | Syracuse | New York | 13215 | United States |
| Neurosurgical Associates | Nashville | Tennessee | 37203 | United States |
| Brain & Spine of Texas | Plano | Texas | 75093 | United States |
| Buda Health Center | Budapest | Hungary |
| Isala Klinieken | Groot Wezenland | Zwolle | 8011 JW | Netherlands |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D007405 | Intervertebral Disc Displacement |
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| D055111 | Failed Back Surgery Syndrome |
| D013120 | Spinal Cord Neoplasms |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014182 | Transplantation, Autologous |
| D014184 | Transplantation, Homologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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