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RECRUITING
NCT06960018
NA

Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement

Sponsor: Aesculap AG

View on ClinicalTrials.gov

Summary

The study's main purpose is the collection of clinical data on the patients benefit and safety of pedicle screw placement through an innovative minimally invasive surgical approach compared to the state of the art open surgical approach using the Ennovate® Cervical Spinal System.

Official title: Controlled, Randomized Clinical Study to Demonstrate the Patient Benefit and Safety of Pedicle Screw Placement Through an Innovative Minimally Invasive Surgical Approach Using the Ennovate® Cervical Spinal System

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2025-06-20

Completion Date

2028-11

Last Updated

2025-06-26

Healthy Volunteers

No

Interventions

DEVICE

Ennovate® Cervical, open surgical technique

Patients with need of posterior monosegmental and multisegmenta stabilization of the cervical and upper thoracic spine, because of * Fractures * Degenerative instability * Post-trauma instability * Tumors * Degenerative cervical myelopathy due to multilevel subaxial spinal canal stenosis will be treated with Ennovate® Cervical system using an open surgical technique

DEVICE

Ennovate® Cervical, minimal invasive surgical technique

Patients with need of posterior monosegmental and multisegmenta stabilization of the cervical and upper thoracic spine, because of * Fractures * Degenerative instability * Post-trauma instability * Tumors * Degenerative cervical myelopathy due to multilevel subaxial spinal canal stenosis will be treated with Ennovate® Cervical system using a minimally invasive technique.

Locations (3)

Universitätsklinikum Aachen

Aachen, Germany

Charité Berlin

Berlin, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany