RECRUITING

PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.

Conditions

Degenerative Disc Disease (DDD)Instabilities Trauma Deformity NDI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3). Primary 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.

Official Title

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

Quick Facts

Study Start:2023-01-13

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05489822

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* Anticipated or documented allergy or intolerance to the materials (e.g., titanium or cobalt chromium). * Active systemic infection or an infection localized to the site of the proposed implantation * Any case in which the chosen implants would be too large or too small to achieve a successful result. * Any patient for whom the use of the implant would conflict with anatomical structures. * Missing bony structures, which would render solid anchoring of the implant impossible (e.g., in the case of fractures, tumors, or osteoporosis). In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure.

Inclusion Criteria

Exclusion Criteria

* 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.

* Anticipated or documented allergy or intolerance to the materials (e.g., titanium or cobalt chromium).
* Active systemic infection or an infection localized to the site of the proposed implantation
* Any case in which the chosen implants would be too large or too small to achieve a successful result.
* Any patient for whom the use of the implant would conflict with anatomical structures.
* Missing bony structures, which would render solid anchoring of the implant impossible (e.g., in the case of fractures, tumors, or osteoporosis). In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure.

Contacts and Locations

Study Contact

Ankit I. Mehta, MD

CONTACT

(847) 826-6280

ankitm@uic.edu

Ralf Klabunde

CONTACT

+49 711 7825 0

rklabunde@silony-medical.com

Principal Investigator

Ankit I. Mehta, MD

PRINCIPAL_INVESTIGATOR

University of Illinois Hospital and Health Sciences System - UI Health

Study Locations (Sites)

University of Illinois Hospital and Health Sciences System - UI Health

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: Silony Medical GmbH

Ankit I. Mehta, MD, PRINCIPAL_INVESTIGATOR, University of Illinois Hospital and Health Sciences System - UI Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-13

Study Completion Date2026-04

Study Record Updates

Study Start Date2023-01-13

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Degenerative Disc Disease (DDD)
Instabilities
Trauma
Deformity