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Completed

NCT Number: NCT01220505

Post Market Surveillance to Evaluate the Effectiveness the 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Torre Auxillo Mutuo, San Juan, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Decreased Operative Time

    Time frame: 6 Months

    Comparison of Operative times vs. literature

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 14, 2010
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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