Registry for spine surgery outcomes
Clariance Registry of ERISMA® and Idys® Devices
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 |
|---|---|
| Enrollment | 760 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clariance Industry-sponsored |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05170815 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who are indicated for treatment with the specified spine devices.
Not a fit: Patients who are unable to comply with study procedures or are contraindicated for spine surgery will not benefit from this study.
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 performed: Other studies have shown success in similar observational approaches, indicating the potential for valuable data collection in real-world settings.
Eligibility criteria
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 this trial is running
Lyon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.