The PerX360º System™ Registry (OptiLIF™)

Interventional Spine

Status: Unknown

Conditions: DDD

Study type: Observational

Funder types: Industry

Identifiers

NCT01796535

TP201

Details and patient eligibility

About

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.

Full 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

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:None

Trial design

125 participants in 1 patient group

PerX360º System™

Description:

Patients treated with PerX360º System™