New 3D-Printed spine implant shows promise in small study
NCT ID NCT04418817
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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36 people
The number who actually took part.
- Started
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Mar 2020
- Finished
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Jan 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Erik C. Spayde, MD Inc.
Thousand Oaks, California, 91360, United States
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Georgia Spine & Neurosurgery Center
Atlanta, Georgia, 30342, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new bone graft match the gold standard for spinal fusion?
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- Can a growth factor from donor bone improve spinal fusion?
- New surgical approach aims to fix failed back fusions by restoring natural spinal curve