Degenerative Disc DiseaseNCT04418817
Modulus in XLIF Study
An observational study of Degenerative Disc Disease and Degenerative Spondylolisthesis, run by NuVasive at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and performance of the Modulus 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as measured by reported complications, radiographic outcomes, and patient-reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2020to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Male or female patients who are ≥18 years of age at the time of surgery
- Treated with XLIF procedure with the Modulus 3D-printed titanium interbody implant at:
- One or two thoracic and/or lumbar levels for degenerative disc disease or degenerative spondylolisthesis, or
- Any number of thoracic and/or lumbar levels for degenerative scoliosis (defined as >10º coronal curve)
- Interbody fusion with autograft and/or allograft
- Any NuVasive supplemental fixation
- 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.
- Patient understands the conditions of enrollment and is willing to sign an informed consent form to participate.
Who cannot join
- 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:
- Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic))
- 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))
- 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))
- Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
- Previous lumbar fusion surgery at the currently treated level(s) (adjacent-level surgery is acceptable)
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- Patients with active infection at the surgical site at the time of surgery
- Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- Patient is unwilling or unable to undergo a CT scan due to pregnancy or other medical condition
- Patient is a prisoner
- Patient is participating in another clinical study that would confound study data
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Georgia Spine & Neurosurgery Center
Atlanta, Georgia, 30342
Erik C. Spayde, MD Inc.
Thousand Oaks, California, 91360
About this study
Official title: An Assessment of the Safety and Performance of the Modulus® 3D-printed Titanium Interbody Implant in Patients Undergoing eXtreme Lateral Interbody Fusion (XLIF®)
The primary objective of this study is to evaluate the safety and performance of the Modulus 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as measured by reported complications, radiographic outcomes, and patient-reported outcomes.
Read the detailed description
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. 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. Available progress notes, medical records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and complications will be obtained from the medical records of all enrolled subjects.
The safety and performance of the Modulus XLIF interbody implant will be assessed using the following:
- Complications attributable to the use of the Modulus XLIF interbody implant as noted in surgical summaries, progress notes, and hospital records
- Radiographic outcome (fusion) and description of device status from plain film radiographs and CT scan(s)
- Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Modulus XLIF Interbody System | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Complications
Rate of complications attributable to use of the Modulus XLIF interbody implant
Measured: At least 12 months
Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative
Proportion of subjects with fusion at 12 months or greater
Measured: At least 12 months
Secondary outcomes (1)
Improvement in neurologic status
Proportion of subjects with neurological improvement as compared to baseline
Measured: At least 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start22 Mar 2020
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Malone, MS, Study director, NuVasive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418817
- Sponsor's protocol ID
- NUVA.X1901
- Status last verified
- Dec 2025
- First submitted
- 2 Jun 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Safety and Performance of the Modulus® 3D-printed Titanium Interbody Implant in Patients Undergoing eXtreme Lateral Interbody Fusion (XLIF®)
- ClinicalTrials.gov ID
- NCT04418817
- Acronym / sponsor ID
- NUVA.X1901
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and performance of the Modulus 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as measured by reported complications, radiographic outcomes, and patient-reported outcomes.
Detailed description
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. 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. Available progress notes, medical records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and complications will be obtained from the medical records of all enrolled subjects.
The safety and performance of the Modulus XLIF interbody implant will be assessed using the following:
- Complications attributable to the use of the Modulus XLIF interbody implant as noted in surgical summaries, progress notes, and hospital records
- Radiographic outcome (fusion) and description of device status from plain film radiographs and CT scan(s)
- Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modulus XLIF Interbody System | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Male or female patients who are ≥18 years of age at the time of surgery
- Treated with XLIF procedure with the Modulus 3D-printed titanium interbody implant at:
- Interbody fusion with autograft and/or allograft
- Any NuVasive supplemental fixation
- 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.
Key exclusion criteria (11 listed)
- 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:
- Previous lumbar fusion surgery at the currently treated level(s) (adjacent-level surgery is acceptable)
- Patients with active infection at the surgical site at the time of surgery
- Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- Patient is unwilling or unable to undergo a CT scan due to pregnancy or other medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Complications
Time frame: At least 12 months
Rate of complications attributable to use of the Modulus XLIF interbody implant
Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative
Time frame: At least 12 months
Proportion of subjects with fusion at 12 months or greater
1 secondary outcome
Improvement in neurologic status
Time frame: At least 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Malone, MS study director
NuVasive
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Degenerative Spondylolisthesis, run by NuVasive at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complications (time frame: At least 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.