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CompletedNCT04418817Updated Dec 22, 2025

Modulus in XLIF Study

An observational study in Degenerative Disc Disease, Degenerative Spondylolisthesis and Degenerative Scoliosis, sponsored by NuVasive. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by NuVasive · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
36
Ages
18 Years and older
Sex
All
01

Study 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 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:

  1. Complications attributable to the use of the Modulus XLIF interbody implant as noted in surgical summaries, progress notes, and hospital records
  2. Radiographic outcome (fusion) and description of device status from plain film radiographs and CT scan(s)
  3. Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available
02

Conditions studied

  • Degenerative Disc Disease
  • Degenerative Spondylolisthesis
  • Degenerative Scoliosis
03

In context

Intervertebral Disc Degeneration

464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.

This study's enrollment of 36 is below the median of 120 across 166 observational studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

NuVasive is the lead sponsor of 38 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
36 participants (actual)
Patient registry
No

Groups and cohorts

  • Modulus XLIF Interbody System
06

What researchers measure

Primary outcomes

  1. Rate of Complications

    Rate of complications attributable to use of the Modulus XLIF interbody implant

    Time frame: At least 12 months

  2. Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative

    Proportion of subjects with fusion at 12 months or greater

    Time frame: At least 12 months

Secondary outcomes

  1. Improvement in neurologic status

    Proportion of subjects with neurological improvement as compared to baseline

    Time frame: At least 12 months

07

Study locations

2 sites
  • Erik C. Spayde, MD Inc.
    Thousand Oaks, California 91360, United States
  • Georgia Spine & Neurosurgery Center
    Atlanta, Georgia 30342, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04418817
Lead sponsor
NuVasive
Responsible party
Sponsor
First posted
Jun 5, 2020
Start date
Mar 22, 2020
Primary completion
Jan 31, 2024
Completion
Jan 31, 2024
Last update
Dec 22, 2025

Study contacts

Kyle Malone, MS
study director · NuVasive

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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