Evaluation of the VERTICALE® Cervical System for spine surgery

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

This study is testing a new cervical spine system to see if it can help people with neck problems feel better and improve their daily activities after surgery.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Silony Medical GmbH (Industry-sponsored)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT05489822 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the clinical performance and safety of the VERTICALE® Cervical System, which is designed for immobilization and stabilization of specific spinal segments. The primary objective is to assess functional outcomes using the Neck Disability Index (NDI) questionnaire, with a hypothesis that NDI scores will improve by at least 10% or 5 points after 12 months compared to preoperative scores. The study aims to enhance surgical procedures for degenerative cervical spine diseases while focusing on patient satisfaction and complication avoidance.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with degenerative disc disease, instabilities, trauma, or deformities requiring surgical intervention.

Not a fit: Patients with allergies to the materials used in the VERTICALE® system or those with active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients with cervical spine conditions.

How similar studies have performed: Other studies evaluating similar spinal stabilization systems have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Relative and absolute contraindications according to IFU (Instruction for Use):

Under certain circumstances, implantation is prohibited or associated with substantial risks, even though there may be an indication for it.

These include in particular:

* 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.

Where this trial is running

Chicago, Illinois

• University of Illinois Hospital and Health Sciences System - UI Health — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Ankit I. Mehta, MD — University of Illinois Hospital and Health Sciences System - UI Health
• Study coordinator: Ankit I. Mehta, MD

Conditions Degenerative Disc Disease; Instabilities; Trauma; Deformity; NDI