Status:
COMPLETED
Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
Lead Sponsor:
Zimmer Biomet
Conditions:
Spinal Deformity
Eligibility:
All Genders
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...
Eligibility Criteria
Inclusion
- 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
- Any subject who does not meet the inclusion criteria
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01220505
Start Date
September 1 2010
End Date
January 1 2014
Last Update
December 19 2019
Active Locations (6)
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1
Orthopedics for Kids, PC
Birmingham, Alabama, United States, 35205
2
Loma Linda University
Loma Linda, California, United States, 92354
3
Children's Orthopedics of Atlanta
Atlanta, Georgia, United States, 30342
4
Orthopedics Indianapolis, P.C.
Indianapolis, Indiana, United States, 46278