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.
Study Type
OBSERVATIONAL
Enrollment
66
All subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System
Orthopedics for Kids, PC
Birmingham, Alabama, United States
Loma Linda University
Loma Linda, California, United States
Children's Orthopedics of Atlanta
Atlanta, Georgia, United States
Orthopedics Indianapolis, P.C.
Indianapolis, Indiana, United States
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.
Time frame: 6 months
Decreased Operative Time
Comparison of Operative times vs. literature
Time frame: 6 Months
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Rochester Hills Orthopedics
Rochester Hills, Michigan, United States
Torre Auxillo Mutuo
San Juan, Puerto Rico