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Spine device study ends early with only 4 patients

NCT ID NCT05489822

Knowledge-focused Sponsor: Silony Medical GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the VERTICALE Cervical System, a device used to stabilize the spine during surgery. Researchers planned to track neck disability in patients with conditions like degenerative disc disease or trauma. Only 4 patients were enrolled before the study was terminated, so the findings are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VERTICALE Cervical System (a medical device for spine stabilization)
What this could lead to
If successful, this study could confirm that the VERTICALE device improves neck function and pain after surgery, supporting its continued use.
What could go wrong
This was a very small study (only 4 patients) and was terminated early, so results may not be reliable or apply to others.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

4 people

The number who actually took part.

Started

Jan 2023

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients (minimum 18 years old) who undergo surgery with the VERTICALE® Cervical System due to one or a combination of the above mentioned indications and give their written consent to participate.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities injury intervertebral disk degenerative disorder lumbar disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Deformity Degenerative disc disease (DDD) Instabilities Trauma

Contacts and locations

Locations

  • University of Illinois Hospital and Health Sciences System - UI Health

    Chicago, Illinois, 60612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.