Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: posterior stabilization for the cervical spine.
- Who it may be relevant to
- Registry conditions: Spine Fracture, Degenerative Disc Disease, Spinal Instability, Spinal Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change of Pain [Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively]
Secondary outcome measures (5)
- Change of Quality of life [Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively]
- Change of Neurological status [Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively]
- Change of Disability [Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively]
- Bone fusion [Time frame: at final follow-up 12 months postoperatively]
- Cumulative number of side effects [Time frame: throughout the follow-up up to 12 months postoperatively]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 4 centers
- Schön Klinik Hamburg Eilbek — Hamburg
- Krankenhaus Ludmillenstift Meppen — Meppen
- Städtisches Klinikum Dresden — Dresden
- Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale — Halle
Identifiers
NCT: NCT05296889 · AAG-O-H-2010