Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To perform a clinical evaluation of safety and performance for the SeaSpine Non- Cervical Pedicle Screw Systems
A multi-center, post-market, clinical evaluation for subjects implanted with the SeaSpine Non-Cervical Pedicle Screw Systems
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated with Non-Cervical Pedicle Screw Systems | 50 patients who have been implanted with SeaSpine Non-Cervical Pedicle Screw Systems |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SeaSpine Non-Cervical Pedicle Screw Systems | Device | Any patient treated with a SeaSpine Non-Cervical Pedicle Screw System |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome for the study is device performance. | Device performance is defined as lack of component failure involving screw and/or rod fracture and/or screw loosening or disassociation. | 12 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of unanticipated adverse device effects (UADE) | Intra or Post-Procedure UADEs | 12-months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients who have been implanted with a SeaSpine Non-Cervical Pedicle Screw System
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frank Vizesi, Ph.D. | SeaSpine, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford | Jackson | Michigan | 49201 | United States | ||
| OrthoNeuro |
Not provided
| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| New Albany |
| Ohio |
| 43054 |
| United States |