Registry for spine surgery outcomes
Official title: Clariance Registry of ERISMA® and Idys® Devices
Run by Clariance · NCT05170815 · Data updated 2026-11-12
This study is collecting information from patients who have spine surgery to see how safe certain devices are and if they help reduce pain and improve daily life over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 760 (estimated) |
| Sponsor | Clariance Industry-sponsored |
| Locations | 1 site (Lyon) |
| Status | Recruiting |
| Started | January 17, 2022 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT05170815 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 or older who are indicated for treatment with the specified spine devices.
✕Probably not a fit
Patients who are unable to comply with study procedures or are contraindicated for spine surgery will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to collect data on patients undergoing spine surgery using specific devices, focusing on their clinical complications and functional outcomes over time. It will gather information preoperatively, intraoperatively, and postoperatively at various intervals, including 9 weeks, 6 months, 1 year, and 2 years. The primary goal is to demonstrate the safety of these devices, while the secondary goal is to assess their effectiveness in reducing pain and improving quality of life and daily activities.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of spine surgery devices, leading to improved patient outcomes.
How similar studies have gone: Other studies have shown success in similar observational approaches, indicating the potential for valuable data collection in real-world settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Considered as adult in the respective geography (18 years old or older for France and 21 years old or older for United-States). * Indicated for treatment with one or more commercially available sponsor spine device included into the study. * For France only, affiliated with or beneficiary of a social security scheme. Exclusion Criteria: * Subjects who are not able to comply with the study procedures based on the judgment of the investigator (e.g., inability to comprehend study related questions, inability to keep scheduled assessment times). * Subjects who are considered as vulnerable: minor, pregnant woman or people under legal protection (guardianship or curatorship). * Contraindicated for spine surgery utilizing a commercially available sponsor spine device.
Where it's running
-
Santy Orthopedic Center
Lyon, France Recruiting
Study contacts
- Study coordinator: Florian Laboulfie
- Email: f.laboulfie@clariance-spine.com
- Phone: +33 7 81 20 03 13
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.