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

Degenerative Disc Disease Clinical Trial

— CERISE  

Official title:

Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05296889
• Other study ID #: AAG-O-H-2010
• Status: Recruiting
• Start date: July 21, 2021
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Aesculap AG
• Contact: Sarah Mattes
• Phone: +497461950
• Email: sarah.mattes[@]aesculap.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Degenerative Myelopathy
• Intervertebral Disc Degeneration
• Spinal Cord Diseases
• Spinal Cord Neoplasms
• Spinal Fractures
• Spinal Instability
• Spinal Neoplasms
• Spinal Tumor
• Spine Fracture

Intervention

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.

Locations

Country	Name	City	State
Germany	Städtisches Klinikum Dresden	Dresden	Sachsen
Germany	Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale	Halle	Sachsen-Anhalt
Germany	Schön Klinik Hamburg Eilbek	Hamburg
Germany	Krankenhaus Ludmillenstift Meppen	Meppen	Niedersachsen

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	Raylytic GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pain	Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which states "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain".	preoperatively, at 3 months postoperatively and at 12 months postoperatively
Secondary	Change of Quality of life	In order to analyze the quality of life of the patients, the 5-dimension 5-level score of EuroQol Group (EQ-5D-5L) is used. The score is self-completed by the patient. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	preoperatively, at 3 months postoperatively and at 12 months postoperatively
Secondary	Change of Neurological status	The Japanese Orthopaedic Association (JOA) myelopathy score is a disease-specific and physician oriented system that mainly assesses the neurological status of the patient and enables surgeons to compare the changes in the neurological status of the patient before and after certain treatments. However, the JOA score does not include patients' satisfaction, disability, handicaps, or general health (physical and mental health), which can be affected by cervical myelopathy.	preoperatively, at 3 months postoperatively and at 12 months postoperatively
Secondary	Change of Disability	The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.	preoperatively, at 3 months postoperatively and at 12 months postoperatively
Secondary	Bone fusion	After cervical stabilization fusion of the treated segment is aspired in most cases. The fusion status can be determined from radiographs (static or dynamic). Bony fusion can be characterized quantitatively by the fusion rate.	at final follow-up 12 months postoperatively
Secondary	Cumulative number of side effects	Occurrence of complications potentially associated with the implanted devices can never be fully excluded during spinal surgery. In order to monitor potential complication and to identify so far unknown complications Adverse Events and Serious Adverse Events deemed related to the investigational device are recorded.	throughout the follow-up up to 12 months postoperatively