Clariance Registry of ERISMAae and Idysae Spine Implant Devices: An Observational Post-Market Follow-up Study

What this Trial Is About

Researchers are conducting an international, prospective, single-arm, multicenter observational study called the Clariance ErYs Registry. This study focuses on evaluating the safety and performance of various spine implant devices in real-world settings. It aims to collect data on complications and functional outcomes related to spine degeneration, spondylosis, deformity, tumors, and fractures. The primary goal is to assess the safety of these devices, while a secondary goal is to evaluate their impact on pain, quality of life, and daily activities. Participants will receive implantation of spine Interbody Fusion Devices and/or Posterior Fixation Systems using different types of ERISMA® and Idys® implants. The study tracks clinical outcomes over multiple time points: preoperative, 9 weeks, 6 months, 1 year, and 2 years after surgery. The implants include various models such as ERISMA® LP/LP EVO, Deformity, MIS, and Idys® devices like TLIF and ALIF with different materials and designs. During the study, participants will undergo evaluations including pain assessment using Visual Analog Score, disability measurement with Oswestry Disability Index, quality of life surveys (SF-12v2®), satisfaction ratings, radiological checks for bone fusion, and monitoring for adverse events or device deficiencies. The research team will review revision rates at two years as the primary outcome. Participant involvement spans about two years with multiple follow-up visits to collect comprehensive safety and performance data.

Clariance ErYs Registry