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

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.

Conditions

Degenerative Disc Disease (DDD), Instabilities, Trauma, Deformity

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Degenerative Disc Disease (DDD)
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Illinois Hospital and Health Sciences System - UI Health, Chicago, Illinois, United States, 60612

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Silony Medical GmbH,

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

Study Record Dates

2026-04