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The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity Correction System.
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity Correction System. We have extended the study tol collect further outcomes data at the 12 month time point.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | All subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Deformity Correction | The primary outcome measure for this trial will be the percentage of subjects who have maintained their degree of deformity correction within 10% from immediate post-op to the 6 month follow-up visit. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decreased Operative Time | Comparison of Operative times vs. literature | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects with a spinal defomrity with a Risser score of a minimum of 3 where the physician has determined that the patient requires a spinal fusion of the thoracic or lumbar spine are eligible for entry into the post market surveillance.
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| Name | Affiliation | Role |
|---|---|---|
| Tammy Stinson | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedics for Kids, PC | Birmingham | Alabama | 35205 | United States | ||
| Loma Linda University |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D007738 | Kyphosis |
| D008141 | Lordosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Loma Linda |
| California |
| 92354 |
| United States |
| Children's Orthopedics of Atlanta | Atlanta | Georgia | 30342 | United States |
| Orthopedics Indianapolis, P.C. | Indianapolis | Indiana | 46278 | United States |
| Rochester Hills Orthopedics | Rochester Hills | Michigan | 48307 | United States |
| Torre Auxillo Mutuo | San Juan | 00917 | Puerto Rico |