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A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.
To gain observational, prospective, real-world clinical, and radiographic data in order to evaluate continued safety and performance following the implantation of SeaSpine products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implanted with SeaSpine spinal or orthobiologics product | Standard of Care Registry- Patients must have been implanted with at least one SeaSpine product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Surgery with SeaSpine product | Device | Implanted with SeaSpine spinal or orthobiologic product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of product failure | Product failure is defined as product fracture, loosening, gross migration and/or dissociation. | 12 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of product-related Serious Adverse Events (SAEs) related to the spine, fusion or bone healing, and intraoperative and postoperative unanticipated adverse device effects | Product-related SAEs related to the spine, fusion, or bone will be collected for this outcome measure. | Intra-operative to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 2285 patients who were previously implanted with SeaSpine products
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| Name | Affiliation | Role |
|---|---|---|
| Frank Vizesi, PhD | SeaSpine Orthopedics Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Colorado | Durango | Colorado | 81301 | United States | ||
| OrthoNeuro |
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| New Albany |
| Ohio |
| 43054 |
| United States |