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

NCT05296889 | Recruiting

• 1 other identifier: AAG-O-H-2010
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

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

Conditions

Spine Fracture; Degenerative Disc Disease; Spinal Instability; Spinal Tumor; Degenerative Myelopathy

Keywords

Cervical Spine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of Quality of life

  preoperatively, at 3 months postoperatively and at 12 months postoperatively

• Change of Neurological status

  preoperatively, at 3 months postoperatively and at 12 months postoperatively

• Change of Disability

  preoperatively, at 3 months postoperatively and at 12 months postoperatively

• Bone fusion

  at final follow-up 12 months postoperatively

• Cumulative number of side effects

  throughout the follow-up up to 12 months postoperatively

Study Arms (1)

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

Interventions

posterior stabilization for the cervical spine DEVICE

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.

Ennovate® Cervical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patient's clear unability or unwillingness to participate in follow-up examinations

Sponsors & Collaborators

• Aesculap AG: lead
• Raylytic GmbH: collaborator

Study Sites (4)

Krankenhaus Ludmillenstift Meppen

Meppen, Lower Saxony, 49716, Germany

NOT YET RECRUITING

Städtisches Klinikum Dresden

Dresden, Saxony, 01076, Germany

NOT YET RECRUITING

Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale

Halle, Saxony-Anhalt, 06112, Germany

RECRUITING

Schön Klinik Hamburg Eilbek

Hamburg, 22081, Germany

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Spinal Fractures; Intervertebral Disc Degeneration; Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Sarah Mattes

CONTACT

+497461950; sarah.mattes@aesculap.de

Stefan Maenz, Dr.

CONTACT

+497461950; stefan.maenz@aesculap.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: July 21, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)