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

Aesculap

Status: Enrolling

Conditions: Spinal Tumor; Degenerative Disc Disease; Spine Fracture; Spinal Instability; Degenerative Myelopathy

Treatments: Device: posterior stabilization for the cervical spine

Study type: Observational

Funder types: Industry

Identifiers

NCT05296889

AAG-O-H-2010

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Ennovate® Cervical

Description:

Alll patients which were treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use

Treatment:

Device: posterior stabilization for the cervical spine