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The objective of this registry study is to collect radiographic and clinical outcome measures to determine the effectiveness of the Saber-C device.
The purpose of this Clinical Registry is to track the real world use the Saber-C cervical fusion device when used for the treatment of Cervical Degenerative Disc Disease from C-2 to T1 for Anterior Cervical Discectomy and Fusion (ACDF). The registry is intended to profile the use of the Saber-C cervical fusion device when used according to surgeon standard of care at clinical practices throughout the United States. The focus of the registry will be to track and better understand the safety, effectiveness and market value of the Saber-C cervical fusion device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saber-C | All enrolled patients will receive the Elevation Spine Saber-C System according to surgeon standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elevation Spine Saber-C System | Device | Device: Elevation Spine Saber-C System Elevation Spine Saber-C System will be fixated between C2 through T1 according to surgeon standard of care at clinical practices through the United States. |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical spinal fusion status assessed via X-rays and CT scans | Cervical spinal fusion status will be assessed via X-rays and CT scans at 1 year post-surgery | 1 year |
| Clinical outcome via neck visual analog scale (VAS) | Standard of care patient reported neck visual analog scale (VAS) will be used to evaluate patient pain. On a scale of 0 to 10 with a score of 0 being no pain and a score of 10 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome. | 1 year |
| Clinical outcome via neck disability index (NDI) | Standard of care patient reported neck disability index (NDI) will be used to evaluate patient pain and quality of life. On a vertical scale of 0 to 5 with a score of 0 meaning neck pain (if any) does not interfere with life activities and 5 meaning neck pain strongly interferes with life activities. A low score means a better clinical outcome. A high score means a worse clinical outcome. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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A patient who meets all inclusion criteria and none exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the Elevation Spine Saber-C System during the surgical procedure. If the surgeon decides intra-operatively not to utilize Saber-C, the patient will be considered a screen failure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strenge Spine | Paducah | Kentucky | 42003 | United States |
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