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The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of the Annexâ„¢ Adjacent Level System for the treatment of adjacent level disease of the lumbar spine. The Annexâ„¢ Adjacent Level System is a spinal fixation system intended to be used with commercially available pedicle screw fixation systems in order to extend existing pedicle screw constructs. Subjects will be evaluated over a 2 year period and compared to historical control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Annex Group | Patients prospectively treated with Annexâ„¢ Adjacent Level System |
| |
| Retrospective Control | Patients previously treated for adjacent level disease using other systems |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Annexâ„¢ Adjacent Level System | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| % Improvement in Operative/Discharge parameters including surgical time and hospital stay | within 30 days after treatment | |
| Surgical Complication rate compared to retrospective chart review | Within 30 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| % Pain reduction on VAS | Up to 2 years post-treatment | |
| % Improvement in Disability using ODI | Up to 2 years post-treatment | |
| % Improvement in Quality of Life using SF-36 |
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Inclusion Criteria:
Exclusion Criteria:
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The subject population for both the treatment and control groups will include adult (skeletally mature) men and women who were previously implanted with rigid posterior fixation (pedicle screw/rod constructs) in the thoracolumbar spine and who later developed adjacent level disease (ALD) at a lumbar level.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Neurosurgery and Spine | Charlotte | North Carolina | 28204 | United States |
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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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| Up to 2 years post-treatment |
| % Patient Satisfaction with procedure | Up to 2 years post-treatment |