Surgery
ProcedureAll subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System
Other names: Polaris Deformity Spinal System, Trivium Deformtiy Correction System
NCT Number: NCT01220505
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.
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Observational
Torre Auxillo Mutuo, San Juan, Puerto Rico
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System
Other names: Polaris Deformity Spinal System, Trivium Deformtiy Correction System
Time frame: 6 months
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
Comparison of Operative times vs. literature
Zimmer Biomet
Industry
A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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