- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01220505
Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
December 17, 2019 updated by: Zimmer Biomet
A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico, 00917
- Torre Auxillo Mutuo
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Alabama
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Birmingham, Alabama, United States, 35205
- Orthopedics for Kids, PC
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California
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Loma Linda, California, United States, 92354
- Loma Linda University
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Georgia
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Atlanta, Georgia, United States, 30342
- Children's Orthopedics of Atlanta
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Indiana
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Indianapolis, Indiana, United States, 46278
- Orthopedics Indianapolis, P.C.
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Michigan
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Rochester Hills, Michigan, United States, 48307
- Rochester Hills Orthopedics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maintenance of Deformity Correction
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decreased Operative Time
Time Frame: 6 Months
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Comparison of Operative times vs. literature
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6 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tammy Stinson, Zimmer Biomet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
October 12, 2010
First Submitted That Met QC Criteria
October 13, 2010
First Posted (Estimate)
October 14, 2010
Study Record Updates
Last Update Posted (Actual)
December 19, 2019
Last Update Submitted That Met QC Criteria
December 17, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS-058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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