Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT01796535
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
Study:
NCT01796535
Study Brief:
Protocol Section:
NCT01796535