Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System
1 other identifier
observational
66
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2010
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 12, 2010
CompletedFirst Posted
Study publicly available on registry
October 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedDecember 19, 2019
December 1, 2019
3.3 years
October 12, 2010
December 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (1)
Decreased Operative Time
6 Months
Interventions
All subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System
Eligibility Criteria
All subjects with a spinal defomrity with a Risser score of a minimum of 3 where the physician has determined that the patient requires a spinal fusion of the thoracic or lumbar spine are eligible for entry into the post market surveillance.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (6)
Orthopedics for Kids, PC
Birmingham, Alabama, 35205, United States
Loma Linda University
Loma Linda, California, 92354, United States
Children's Orthopedics of Atlanta
Atlanta, Georgia, 30342, United States
Orthopedics Indianapolis, P.C.
Indianapolis, Indiana, 46278, United States
Rochester Hills Orthopedics
Rochester Hills, Michigan, 48307, United States
Torre Auxillo Mutuo
San Juan, 00917, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tammy Stinson
Zimmer Biomet
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2010
First Posted
October 14, 2010
Study Start
September 1, 2010
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
December 19, 2019
Record last verified: 2019-12