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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01220505

Enrollment

Registered

2010-10-14

Start date

2010-09-30

Completion date

2014-01-31

Last updated

2019-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Deformity

Keywords

scoliosis, kyphosis, spinal deformity, curvature, lordosis

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.

Interventions

PROCEDURESurgery

All subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Maintenance of Deformity Correction	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.

Secondary

Measure	Time frame	Description
Decreased Operative Time	6 Months	Comparison of Operative times vs. literature

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026