NCT01796535

The PerX360º System™ Registry

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: Interventional Spine, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• DDD

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-02-21
• Last updated: 2013-03-15

Locations

2 sites across 1 country: United States