NCT05296889

Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical

Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications

Detailed description

This clinical study is one of the Post market clinical follow-up measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Cervical system. The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in trauma and degenerative disorders.

Conditions

• Spine Fracture
• Degenerative Disc Disease
• Spinal Instability
• Spinal Tumor
• Degenerative Myelopathy

Interventions

Type	Name	Description
DEVICE	posterior stabilization for the cervical spine	The Ennovate® Cervical Spinal System is a posterior stabilization for the cervical and upper-thoracic spine. The implants are used for the posterior monosegmental and multisegmental stabilization of the occipitocervical junction and of the cervical and upper thoracic spine.

Timeline

• Start date: 2021-07-21
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2022-03-25
• Last updated: 2026-03-31

Locations

4 sites across 1 country: Germany