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Summary
International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting. The primary objective is to demonstrate that the use of the study devices is safe. The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.
Official title: Clariance Registry of ERISMA® and Idys® Devices
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
760
Start Date
2022-01-17
Completion Date
2028-12
Last Updated
2026-03-17
Healthy Volunteers
No
Interventions
Spine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Locations (1)
Santy Orthopedic Center
Lyon, France