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3D-Printed spinal cages could revolutionize back surgery

NCT ID NCT05237908

Disease control 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study compares two types of implants used in spinal fusion surgery: 3D-printed cages and titanium-coated cages. The goal is to see which leads to better bone fusion and less disability for patients with herniated discs or degenerative spine disease. About 78 adults undergoing lumbar fusion will be randomly assigned to one implant type and followed for clinical outcomes like pain and quality of life.

What this could mean

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

Active substance
3D-printed interbody fusion cage
What this could lead to
If 3D-printed cages prove better, they could become the new standard for spinal fusion, potentially improving recovery and reducing long-term disability.
What could go wrong
This is a small, early-stage device comparison. Results may not show a clear advantage, and individual surgical outcomes vary widely.

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

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Aug 2028

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

Patients will be recruited consecutively. No selection besides the inclusion and exclusion criteria will take place.

Ages

18 to 79 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: * Indication for one, two or three-segment lumbar interbody fusion according to Instructions for use * Written informed consent for the documentation of clinical and radiological results * Willingness and mental ability to participate at the follow-up examinations Exclusion Criteria: * Patient is not willing or able to participate at the follow-up examination * Patient age \< 18 years and \>80 years * Patient is pregnant * Previous instrumented lumbar spine surgery

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder lumbar disk herniation, susceptibility to spondylolisthesis

As listed by the trial registrant

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

Disc disease degenerative Disk herniated lumbar Spondylolisthesis

Contacts and locations

Locations

  • BG Unfallklinik Frankfurt am Main

    Frankfurt am Main, Hesse, 60389, Germany

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