RecruitingNCT05296889

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

Sponsor

Aesculap AG

Enrollment

200 participants

Start Date

Jul 21, 2021

Study Type

OBSERVATIONAL

Conditions

Degenerative Disc Disease Spinal Tumor Spine Fracture Spinal Instability Degenerative Myelopathy

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a post-market study tracking the long-term safety and performance of the Ennovate® Cervical system — a device used in the neck (cervical spine) to stabilize vertebrae — in patients who have already received it as part of their standard surgical care. **You may be eligible if...** - You are 18 years or older - You have had the Ennovate® Cervical device implanted as indicated by its instructions for use - You consent to having your clinical and imaging results documented for the study - You are not pregnant **You may NOT be eligible if...** - You are unwilling or unable to attend follow-up examinations 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

DEVICEposterior 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.