Monitoring the safety and performance of Ennovate® Cervical implants
Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications
This study is looking at how safe and effective the Ennovate® Cervical implants are for patients with different spinal problems like fractures and disc disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 4 sites (Meppen, Lower Saxony and 3 other locations) |
| Trial ID | NCT05296889 on ClinicalTrials.gov |
What this trial studies
This observational study collects data on the safety and performance of the Ennovate® Cervical system used in patients with various spinal conditions. It aims to document clinical outcomes and evaluate the efficacy of the implant system in treating spine fractures, degenerative disc disease, spinal instability, spinal tumors, and degenerative myelopathy. The study involves multiple centers and focuses on gathering detailed information from patients who have received the implant, ensuring comprehensive follow-up and assessment of results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require cervical spine stabilization and meet the study's inclusion criteria.
Not a fit: Patients who are unable or unwilling to participate in follow-up examinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the Ennovate® Cervical system's effectiveness and safety, leading to improved patient outcomes.
How similar studies have performed: Other studies on post-market surveillance of spinal implants have shown success in monitoring safety and performance, indicating that this approach is validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is minimum 18 years old * Informed Consent in the documentation of clinical and radiological results * Patient has indication according to Instructions for Use (IFU) * Patient is not pregnant Exclusion Criteria: * Patient's clear unability or unwillingness to participate in follow-up examinations
Where this trial is running
Meppen, Lower Saxony and 3 other locations
- Krankenhaus Ludmillenstift Meppen — Meppen, Lower Saxony, Germany (Not_yet_recruiting)
- Städtisches Klinikum Dresden — Dresden, Saxony, Germany (Not_yet_recruiting)
- Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale — Halle, Saxony-Anhalt, Germany (Recruiting)
- Schön Klinik Hamburg Eilbek — Hamburg, Germany (Active_not_recruiting)
Study contacts
- Study coordinator: Sarah Mattes
- Email: sarah.mattes@aesculap.de
- Phone: +497461950
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.