Clinical trial NCT05296889: Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Official title: Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spine Fracture
Degenerative Disc Disease
Spinal Instability
Spinal Tumor
Degenerative Myelopathy
Keywords: Cervical Spine
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: Raylytic GmbH
First posted: 2022-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use: fractures, degenerative instability, post-trauma instability, tumors, degenerative cervical myelopathy

Brief 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.

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

Primary outcomes:
measure: Change of Pain
timeFrame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Secondary outcomes:
measure: Change of Quality of life
timeFrame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
measure: Change of Neurological status
timeFrame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
measure: Change of Disability
timeFrame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
measure: Bone fusion
timeFrame: at final follow-up 12 months postoperatively
measure: Cumulative number of side effects
timeFrame: throughout the follow-up up to 12 months postoperatively
Other outcomes:
Locations:
city: Meppen
country: Germany
facility: Krankenhaus Ludmillenstift Meppen
state: Niedersachsen
city: Halle
country: Germany
facility: Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden
state: Sachsen
city: Hamburg
country: Germany
facility: Schön Klinik Hamburg Eilbek
Study officials:
References: