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New 3D-Printed spine implant shows promise in small study

NCT ID NCT04418817

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new 3D-printed titanium implant for spine fusion surgery in 36 adults with degenerative disc disease, spondylolisthesis, or scoliosis. The implant is designed to help bones in the spine grow together after surgery. Researchers looked at safety, how well the bones fused, and patient-reported outcomes. The goal was to see if the implant works well and is safe for use.

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

36 people

The number who actually took part.

Started

Mar 2020

Finished

Jan 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 considered for this study will have previously undergone surgery for their spinal condition according to the standard of care of the practitioner. All patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. Once enrolled in the study, subjects will undergo a computed tomography (CT) scan at 12 months postoperative or later to evaluate their fusion status.

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: 1. Male or female patients who are ≥18 years of age at the time of surgery 2. Treated with XLIF procedure with the Modulus 3D-printed titanium interbody implant at: 1. One or two thoracic and/or lumbar levels for degenerative disc disease or degenerative spondylolisthesis, or 2. Any number of thoracic and/or lumbar levels for degenerative scoliosis (defined as \>10º coronal curve) 3. Interbody fusion with autograft and/or allograft 4. Any NuVasive supplemental fixation 5. Patient is able and to undergo a CT scan. If the patient already had a postoperative CT scan at 12 months or greater, this will be used in this study and an additional CT scan should not be performed for this study. 6. Patient understands the conditions of enrollment and is willing to sign an informed consent form to participate. Exclusion Criteria: 1. Use of any bone graft with the Modulus XLIF interbody implant that is not FDA-cleared for use in the interbody space. Examples of these include: 1. Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic)) 2. Synthetic bone graft extenders (e.g., AttraX (NuVasive), Formagraft (NuVasive), Mastergraft (Medtronic), Vitoss (Stryker), Actifuse (Baxter), nanOss (RTI Surgical), Fibergraft (Prosidyan/Depuy Synthes), ChronOs (Depuy Synthes)) 3. Demineralized bone matrices (DBM) regulated as medical devices by the FDA (e.g., Grafton Putty/Gel (Medtronic), DBX (MTF/Depuy Synthes), Accell Evo3 (IsoTis), Propel Putty/Gel (NuVasive)) 4. Peptide enhanced bone graft (e.g., iFactor (Cerapedics)) 2. Previous lumbar fusion surgery at the currently treated level(s) (adjacent-level surgery is acceptable) 3. Patients with active infection at the surgical site at the time of surgery 4. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested) 5. Patient is unwilling or unable to undergo a CT scan due to pregnancy or other medical condition 6. Patient is a prisoner 7. Patient is participating in another clinical study that would confound study data

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Erik C. Spayde, MD Inc.

    Thousand Oaks, California, 91360, United States

  • Georgia Spine & Neurosurgery Center

    Atlanta, Georgia, 30342, United States

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