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

NCT06960018 | Recruiting

• 1 other identifier: AAG-O-H-23045
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cervical Spine Disease; Pain, Postoperative

Keywords

posterior cervical fusion; pedicle screw

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain". Pain will be recorded at minimum 12 months postoperatively, if available in the preoperative clinical routine data, it will also be recorded in the study.

  4 (+/- 1 day) postoperative

Secondary Outcomes (6)

• Screw placement accuracy

  intraoperative or discharge visit (approx. 10 days post op.)

• Neck Disability Index (NDI)

  praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)

• Quality of Life (EQ-5D-5L)

  praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)

• Quality of Life (EQ-VAS)

  praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)

• Rate of Adverse Events / Serious Adverse Events

  During the course of the study up to two years postoperatively

Study Arms (2)

Implantation Ennovate® Cervical system using an open surgical technique

ACTIVE COMPARATOR

Device: Ennovate® Cervical, open surgical technique

Implantation Ennovate® Cervical system using a minimally invasive technique.

EXPERIMENTAL

Device: Ennovate® Cervical, minimal invasive surgical technique

Interventions

Ennovate® Cervical, open surgical technique DEVICE

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

Implantation Ennovate® Cervical system using an open surgical technique

Ennovate® Cervical, minimal invasive surgical technique DEVICE

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.

Implantation Ennovate® Cervical system using a minimally invasive technique.

Eligibility Criteria

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

You may qualify if:

• All patients with minimum 18 years of age receiving Ennovate® Cervical internal fixation device within the vertebral bodies C2-Th3 to ensure the restoration and stabilization of the cervical spine

You may not qualify if:

• All patients not willing to sign the patient consent are excluded. Also, if it is clear from the beginning, that the patient will not be able to come to routine follow-up, the patient will also be excluded.
• Absolute contraindications according to the IFU:
• Severe damage to the bone structures of the spine that could prevent the stable implantation of the implant components; for example, osteopenia, severe osteoporosis, Paget's disease, bone tumors etc.
• Metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant system.
• Suspected allergy or sensitivity to the implant materials.
• Acute or chronic vertebral infections of a local or systemic nature.
• Poor patient compliance or limited ability to follow medical instructions, particularly in the postop phase, including with regard to the restrictions on range of movement in terms of physical exercise and occupational activity.

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (3)

Universitätsklinikum Aachen

Aachen, 52074, Germany

RECRUITING

Charité Berlin

Berlin, 10117, Germany

RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, 70196, Germany

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Sarah Mattes

CONTACT

+497461; studies@aesculap.de

Stefan Maenz, Dr.

CONTACT

+497461; studies@aesculap.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Block randomization with random block length will be used. The electronic data capture system will instruct the clinical investigator to use either the open or the minimally invasive surgical technique.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomly allocated to one of the two study groups in a 1:1 ratio. In addition, stratification by clinical investigation sites is applied. Group 1: Patients treated with the Ennovate® Cervical system using an open surgical technique. Group 2: Patients treated with the Ennovate® Cervical system using a minimally invasive technique. Study is designed to provide a comparison of the both groups regarding the short-term pain outcome.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 7, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)