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

Zimmer Biomet6 sites in 2 countries66 target enrollmentSeptember 2010

ConditionsSpinal Deformity

Overview

Phase: N/A
Intervention: Not specified
Conditions: Spinal Deformity
Sponsor: Zimmer Biomet
Enrollment: 66
Locations: 6
Primary Endpoint: Maintenance of Deformity Correction
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 have extended the study tol collect further outcomes data at the 12 month time point.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

January 2014

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility 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 ≥
•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

Outcomes

Primary Outcomes

Maintenance of Deformity Correction

Time Frame: 6 months

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.