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

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

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

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Spinal Tumor; Degenerative Myelopathy; Spine Fracture; Spinal Instability
• Intervention / Treatment: Device: posterior stabilization for the cervical spine

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Sarah Mattes; Phone Number: +497461950; Email: sarah.mattes@aesculap.de
• Study Contact Backup: Name: Stefan Maenz, Dr.; Phone Number: +497461950; Email: stefan.maenz@aesculap.de

Study Locations

• Germany
  • Hamburg, Germany, 22081
    • Active, not recruiting
    • Schön Klinik Hamburg Eilbek
  • Niedersachsen
    • Meppen, Niedersachsen, Germany, 49716
      • Not yet recruiting
      • Krankenhaus Ludmillenstift Meppen
      • Contact: Felix Kiepe, Dr.
      • Principal Investigator: Felix Kiepe, Dr.
  • Sachsen
    • Dresden, Sachsen, Germany, 01076
      • Not yet recruiting
      • Stadtisches Klinikum Dresden
      • Contact: Philip Gierer, Prof. Dr.
      • Principal Investigator: Gierer, Prof. Dr.
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 06112
      • Recruiting
      • Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale
      • Contact: Klaus Röhl, Dr.
      • Principal Investigator: Klaus Röhl, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ennovate® Cervical; Alll patients which were treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: Raylytic GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cervical Spine
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Diseases; Bone Diseases; Spinal Injuries; Back Injuries; Bone Neoplasms; Intervertebral Disc Degeneration; Spinal Cord Diseases; Spinal Fractures; Spinal Cord Neoplasms; Spinal Neoplasms
• Other Study ID Numbers: AAG-O-H-2010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No