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The purpose of this open, multi-center study is to prospectively collect outcome data on patients who are having lumbar spinal fusion surgery with implantation of the SpineLink® system.
This will be an open, prospective, multi-center outcome study. This study will be conducted at up to ten centers, each of which will enroll approximately 20 patients. A maximum of 200 patients will be enrolled. This patient sample size will allow statistical comparison to historical literature and allow an inter-center comparison of outcome. Enrollment into the study may include all patients who have lumbar spinal fusion performed. All spinal fusion surgery will be performed using the EBI SpineLink® system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpineLink® , SpineLink® II Group | Spinal fusion surgery with SpineLink® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpineLink® , SpineLink® II | Device | Spine plate system for lumbar spinal fusions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of successful fusions achieved | AP radiographs will be evaluated for the evidence of bridging virgin trabecular bone across the fusion mass. In order for a patient to be considered fused, A/P radiographs must show evidence of bridging virgin trabecular bone across the fusion mass. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurologic Assessment | Maintenance or Improvement | 24 Months |
| Radiographic Fusion Grade | Radiographic fusion grade will be assessed at each follow up, as defined by Dawson et al. 8, as follows: A0 = Pseudarthrosis A1 = Unilateral Pseudarthrosis A2 = Insufficient Unilateral Bone Mass A3 = Contiguous Fusion without Hypertrophy A4 = Solid Fusion with Hypertrophy of Fusion Mass |
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Inclusion Criteria:
Exclusion Criteria:
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Multiple site around the US
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alvarado Orthopedic Clinic | San Diego | California | 92120 | United States | ||
| Rogozinski Orthopedic Clinic |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| 24 Months |
| SF-36 Health Survey | Health Survey | 24 Months |
| Jacksonville |
| Florida |
| 32216 |
| United States |
| D055009 |
| Spondylosis |