A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System
Verified March 2014 by Biomet, Inc.
Information provided by (Responsible Party):
First received: October 12, 2010
Last updated: March 19, 2014
Last verified: March 2014
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
All subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System
- Polaris Deformity Spinal System
- Trivium Deformtiy Correction 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. We have extended the study tol collect further outcomes data at the 12 month time point.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- Any subject who does not meet the inclusion criteria
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220505
|Orthopedics for Kids, PC
|Birmingham, Alabama, United States, 35205 |
|Loma Linda University
|Loma Linda, California, United States, 92354 |
|Contact: Elisabeth A Clarke 909-558-6444 EAClarke@llu.edu |
|Principal Investigator: Wayne K Cheng, MD |
|Children's Orthopedics of Atlanta
|Atlanta, Georgia, United States, 30342 |
|Orthopedics Indianapolis, P.C.
|Indianapolis, Indiana, United States, 46278 |
|Rochester Hills Orthopedics
|Rochester Hills, Michigan, United States, 48307 |
|Torre Auxillo Mutuo
|San Juan, Puerto Rico, 00917 |
||Betsy Lowry, CCRP
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 12, 2010
||March 19, 2014
||United States: Institutional Review Board
Keywords provided by Biomet, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014