DDD
Conditions
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
Interventions
None listed
Sponsors
Interventional Spine, Inc.
Study design
Observational model
CASE_ONLY
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion | 1 year | Image Assessment |
Countries
United States
Contacts
Primary ContactMichelle Butler
Outcome results
None listed