Modulus in XLIF Study

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease; Degenerative Scoliosis; Degenerative Spondylolisthesis

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

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Modulus XLIF Interbody System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Complications	Rate of complications attributable to use of the Modulus XLIF interbody implant	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	At least 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in neurologic status	Proportion of subjects with neurological improvement as compared to baseline	At least 12 months

Collaborators and Investigators

• Sponsor: NuVasive
• Investigators: Study Director: Kyle Malone, MS, NuVasive

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2020
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: NUVA.X1901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No