Sponsor-initiated, Prospective, Single-center, Non-interventional Clinical Observational Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Objective: To assess the functional outcome and clinical benefit of the VERTICALE® Cervical System for the patient using the NDI (Neck Disability Index) questionnaire. Primary endpoint hypothesis: The investigators hypothesize that NDI improves by at least 10% or 5 points at 12 months FU (Follow-Up) compared with preoperatively.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Ability to read, understand and speak the local language fluently to ensure understanding of Informed consent and protocol specific investigations

• The surgical indication must be one or a combination of the following

• Degenerative disc disease (DDD)

• Instabilities

• Trauma

• Deformities

• Mono-, bi- and multisegmental restoration (occipital T3)

• Age: ≥ 18 years

• The subject must give written informed consent before inclusion into the PMCF study.

Locations
United States
Illinois
University of Illinois Hospital and Health Sciences System - UI Health
RECRUITING
Chicago
Contact Information
Primary
Ankit I. Mehta, MD
ankitm@uic.edu
(847) 826-6280
Backup
Ralf Klabunde
rklabunde@silony-medical.com
+49 711 7825 0
Time Frame
Start Date: 2023-01-13
Estimated Completion Date: 2026-04
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Leads: Silony Medical GmbH

This content was sourced from clinicaltrials.gov