An Observational, Multi Center, Non-Randomized (Single Arm) Registration of the PerX360º System™
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- DDD
- Sponsor
- Interventional Spine, Inc.
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- Fusion
- Last Updated
- 13 years ago
Overview
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
Investigators
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
Fusion
Time Frame: 1 year
Image Assessment