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Spine device study pulled before it began

NCT ID NCT05944081

Knowledge-focused Sponsor: Aesculap AG 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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study was designed to check how well the Arcadius XP L spine fusion device works and if it is safe for people with chronic low-back pain from conditions like degenerative disc disease or instability. The plan was to follow 60 patients for at least one year after surgery. However, the study was withdrawn before any patients were enrolled, so no new data was collected.

What this could mean

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

Active substance
Arcadius XP L interbody fusion device

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.

Started

Mar 2024

Expected to finish

Dec 2025

An estimate. End dates often move.

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

All patients that received an Arcadius XP L® interbody fusion device in accordance with the indications given in the instructions for use:

Ages

18 to 60 years

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: * all patients who received a Arcadius XP L® interbody fusion device between 2016 until approx. January 2021 (minimum Follow-up is one year) in the study center * all indications as given by the instructions for use: degenerative disc disease (DDD), Instability, Spondylolisthesis up to grade 1, Post-discectomy syndrome, Post-traumatic instability * Written informed consent for the documentation of clinical and radiological results Exclusion Criteria: * Patient is not willing or able to participate at the follow-up examination * Patients living outside a radius of 100 km around the study center * all contraindications as given by the instructions for use:

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder spondylolisthesis spondylolysis

As listed by the trial registrant

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

Chronic low-back pain Degenerative disc disease Postdiscectomy syndrome Posttraumatic instability Spondylolysis lumbar

Contacts and locations

Locations

  • Medius Klinik Nürtingen

    Nürtingen, Baden-Wurttemberg, 72622, Germany

  • Rems-Murr-Klinik Schorndorf

    Schorndorf, Baden-Wurttemberg, 73614, Germany

  • Schelztor-Klinik Esslingen

    Esslingen am Neckar, Baden-Wurttemberg, 73728, Germany

More trials for these conditions

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