The PerX360º System™ Registry — OptiLIF™  

DDD Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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 ;

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• DDD

• NCT number: NCT01796535
• Study type: Observational [Patient Registry]
• Source: Interventional Spine, Inc.
• Contact: Michelle Butler
• Phone: 858 220 6904
• Email: mbutler@i-spineinc.com
• Status: Recruiting
• Phase: N/A
• Start date: November 2012
• Completion date: June 2013