RecruitingNCT05170815

Clariance ErYs Registry

Clariance Registry of ERISMA® and Idys® Devices

Sponsor

Clariance

Enrollment

760 participants

Start Date

Jan 17, 2022

Study Type

OBSERVATIONAL

Conditions

Spinal Tumor Spinal Deformity Spine Degeneration Spine Spondylosis Thoracic Spinal Fracture

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a registry collecting long-term data from patients who have received spine surgery using a specific brand of spinal implant devices (Clariance ErYs). It is not a treatment trial — researchers simply want to track how patients do over time after spine surgery to understand the safety and performance of these devices in real-world use. You may be eligible if: - You are 18 years or older (or 21 and older if in the United States) - You are receiving treatment with one of the Clariance ErYs spine devices - You are affiliated with a social security scheme (for France participants) You may NOT be eligible if: - You are unable to comply with study procedures or scheduled assessments - You are a minor, pregnant woman, or under legal protection (guardianship) - You have a contraindication to spine surgery using the relevant device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESpine surgery

Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.

Locations(1)

Santy Orthopedic Center

Lyon, France

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NCT05170815

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