Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System

Completed

• Conditions: Spinal Deformity

• Registration Number: NCT01220505
• Lead Sponsor: Zimmer Biomet

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 200 subjects at 10 clinical centers.
• All subjects undergoing spinal fusion surgery between the levels of T1- Ilium (Thoracic 1 to Ilium)
• All subjects are skeletally mature with spinal deformity.
• Risser score must be ≥ 3.
• Subjects or their representative must be willing and able to give informed consent and assent (if applicable).
• Subjects who do not meet any of the following contraindications: spinal infection or inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal sensitivity, foreign body sensitivity, patients with inadequate tissue coverage over the operative site, open wounds local to the operative area, any case not described in the specific indications

Exclusion Criteria

• Any subject who does not meet the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maintenance of Deformity Correction	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.

Secondary Outcome Measures

Name	Time	Method
Decreased Operative Time	6 Months	Comparison of Operative times vs. literature

Trial Locations

Locations (6)

Torre Auxillo Mutuo; 🇵🇷 San Juan, Puerto Rico

Loma Linda University; 🇺🇸 Loma Linda, California, United States

Orthopedics for Kids, PC; 🇺🇸 Birmingham, Alabama, United States

Children's Orthopedics of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Rochester Hills Orthopedics; 🇺🇸 Rochester Hills, Michigan, United States

Orthopedics Indianapolis, P.C.; 🇺🇸 Indianapolis, Indiana, United States