A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01220505
First received: October 12, 2010
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Spinal Deformity
Procedure: Surgery
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Maintenance of Deformity Correction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Fusion Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subjects with radiographic evidence of fusion consolidation

  • Decreased Operative Time [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Comparison of Operative times vs. literature


Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Surgery
    All subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System
    Other Names:
    • Polaris Deformity Spinal System
    • Trivium Deformtiy 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 have extended the study tol collect further outcomes data at the 12 month time point.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
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

Contacts
Contact: Betsy Lowry, CCRP 800-526-2579 ext 2218 betsy.lowry@biomet.com

Locations
United States, Alabama
Orthopedics for Kids, PC Completed
Birmingham, Alabama, United States, 35205
United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92354
Contact: Elisabeth A Clarke    909-558-6444    EAClarke@llu.edu   
Principal Investigator: Wayne K Cheng, MD         
United States, Georgia
Children's Orthopedics of Atlanta Completed
Atlanta, Georgia, United States, 30342
United States, Indiana
Orthopedics Indianapolis, P.C. Completed
Indianapolis, Indiana, United States, 46278
United States, Michigan
Rochester Hills Orthopedics Completed
Rochester Hills, Michigan, United States, 48307
Puerto Rico
Torre Auxillo Mutuo Completed
San Juan, Puerto Rico, 00917
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Director: Betsy Lowry, CCRP Biomet Spine
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01220505     History of Changes
Other Study ID Numbers: CS-058
Study First Received: October 12, 2010
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
scoliosis
kyphosis
spinal deformity
curvature
lordosis

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014