The PerX360º System™ Registry

DDD Clinical Trial

— OptiLIF™  

Official title:

An Observational, Multi Center, Non-Randomized (Single Arm) Registration of the PerX360º System™

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01796535
• Other study ID #: TP201
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2012
• Last updated: March 13, 2013
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: March 2013
• Source: Interventional Spine, Inc.
• Contact: Michelle Butler
• Phone: 858 220 6904
• Email: mbutler[@]i-spineinc.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a multi-center, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should be per standard of care.

Description:

For all patients participating in the registry, the following outcomes will be analyzed:

• Change in pain score on the Visual Analog Scale(VAS) from baseline for leg pain

• Change in pain score on the Visual Analog Scale(VAS) from baseline for back pain

• Change in Oswestry Disability Index (ODI) score from baseline

• Proportion of patients with a device related complication

• Proportion of patients with lack of revision, removal, or reoperation

• Proportion of patients with radiographic fusion

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient understands the nature of the procedure and provides written informed consent

• Patient is willing to return to the treating physician for his/her routine follow-up visits up to 12 months post treatment

• Age > 18 years

• Patient is treated with the Optiport™ and Opticage™ products

Exclusion Criteria:None

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• DDD

Locations

Country	Name	City	State
United States	Los Angeles Brain and Spine Institute	Los Angeles	California
United States	Flagler Hospital	St. Augustine	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Interventional Spine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion	Image Assessment	1 year	No