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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-21

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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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

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Spine Fracture Degenerative Disc Disease Spinal Instability Spinal Tumor Degenerative Myelopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ennovate® Cervical

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

posterior stabilization for the cervical spine

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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