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

Completed

Conditions studied: Spinal Deformity

In brief

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.

Key facts

Study ID

NCT01220505

Run by

Zimmer Biomet

People needed

66

Starts

2010-09-01

Expected to finish

2014-01-01

Last updated by the study team

2019-12-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any subject who does not meet the inclusion criteria

Where it is running

• 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
• Rochester Hills Orthopedics — Rochester Hills, Michigan, United States
• Torre Auxillo Mutuo — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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