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The purpose of this study is to evaluate the efficacy of SeaSpine Shoreline device in surgery of the cervical spine.
This is a retrospective, prospective, post-market, observational, single-center, single surgeon study evaluating the use of the SeaSpine Shoreline device. Patients will be identified by the Investigator as needing, or already received the device during a cervical fusion surgery and meeting all the inclusion and none of the exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SeaSpine Shoreline | All enrolled patients will receive the SeaSpine Shoreline device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SeaSpine Shoreline | Device | The SeaSpine Shoreline device is a minimally invasive cervical plate/cage system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cervical fusion assessed via CT scan | Motion, bridging on radiograph, and bridging bone on CT scan | 12 months post surgery |
| 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. | 12 months post surgery |
| 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. | 12 months post surgery |
| Clinical outcome via Dysphagia score | Standard of care patient reported dysphagia score will be used to evaluate patient inability or difficulty swallowing. On a scale of 0 to 4 with a score of 0 meaning no difficulty and 4 meaning severe problem. A low score means a better clinical outcome. A high score means a worse clinical outcome. | 12 months post surgery |
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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 SeaSpine Shoreline device during the surgical procedure. If the surgeon decides intra-operatively not to utilize the SeaSpine Shoreline device, the patient will be considered a screen failure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Orthopaedic Surgeons | Southfield | Michigan | 48033 | United States |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |