Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System

Spinal Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220505
• Other study ID #: CS-058
• Status: Completed
• Start date: September 2010
• Est. completion date: January 2014

Study information

• Verified date: December 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity

Intervention

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

Locations

Country	Name	City	State
Puerto Rico	Torre Auxillo Mutuo	San Juan
United States	Children's Orthopedics of Atlanta	Atlanta	Georgia
United States	Orthopedics for Kids, PC	Birmingham	Alabama
United States	Orthopedics Indianapolis, P.C.	Indianapolis	Indiana
United States	Loma Linda University	Loma Linda	California
United States	Rochester Hills Orthopedics	Rochester Hills	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of Deformity Correction	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.	6 months
Secondary	Decreased Operative Time	Comparison of Operative times vs. literature	6 Months