The PerX360º System™ Registry
- Conditions
- DDD
- Registration Number
- NCT01796535
- Lead Sponsor
- Interventional Spine, Inc.
- Brief 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 125
- 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
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fusion 1 year Image Assessment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Flagler Hospital
🇺🇸St. Augustine, Florida, United States
Los Angeles Brain and Spine Institute
🇺🇸Los Angeles, California, United States