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

Recruiting

• Conditions: Spine Fracture; Degenerative Disc Disease; Spinal Instability; Spinal Tumor; Degenerative Myelopathy
• Interventions: Device: posterior stabilization for the cervical spine

• Registration Number: NCT05296889
• Lead Sponsor: Aesculap AG

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.

Study Timeline

• Study Start: 2021-07-21
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ennovate® Cervical	posterior stabilization for the cervical spine	Alll patients which were treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use

Primary Outcome Measures

Name	Time	Method
Change of Pain	preoperatively, at 3 months postoperatively and at 12 months postoperatively	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".

Secondary Outcome Measures

Name	Time	Method
Change of Disability	preoperatively, at 3 months postoperatively and at 12 months postoperatively	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.
Bone fusion	at final follow-up 12 months postoperatively	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.
Cumulative number of side effects	throughout the follow-up up to 12 months postoperatively	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.
Change of Quality of life	preoperatively, at 3 months postoperatively and at 12 months postoperatively	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.
Change of Neurological status	preoperatively, at 3 months postoperatively and at 12 months postoperatively	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.

Trial Locations

Locations (4)

Krankenhaus Ludmillenstift Meppen; 🇩🇪 Meppen, Niedersachsen, Germany

Städtisches Klinikum Dresden; 🇩🇪 Dresden, Sachsen, Germany

Schön Klinik Hamburg Eilbek; 🇩🇪 Hamburg, Germany

Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale; 🇩🇪 Halle, Sachsen-Anhalt, Germany