Retrospective Modulus ALIF Study

An Assessment of the Safety and Performance of the Modulus® ALIF System in Patients Undergoing Anterior Lumbar Interbody Fusion

The primary objective of this study is to evaluate the safety and performance of the Modulus ALIF System in patients undergoing anterior lumbar interbody fusion (ALIF) as measured by reported complications, radiographic outcomes, and patient-reported outcomes.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease; Spondylolisthesis; Stenosis
• Intervention / Treatment: Device: Modulus ALIF System

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 considered for participation in the 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 complication profile and overall performance of the Modulus ALIF System will be assessed using the following:

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

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Hoag Orthopedics
    • San Diego, California, United States, 92121
      • Girard Orthopedic Surgeons
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Georgia Spine & Neurosurgery Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina
    • Wilmington, North Carolina, United States, 28401
      • Atlantic Brain and Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The analysis population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:

• Satisfied the inclusion and exclusion criteria
• Previously underwent the surgical procedure as defined in this protocol

Description

Inclusion Criteria:

1. Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery
2. Male or female patients who are ≥18 years of age at the time of surgery
3. Had undergone a regiment of at least six (6) months of nonoperative care treatment prior to being treated with the Modulus ALIF system, except in patients with progressive neurological deficits, neurogenic claudication causing significant disability, or developed cauda equine syndrome

4. Treated with ALIF procedure with the Modulus ALIF System at:

   • One or two adjacent lumbar and/or lumbosacral levels for degenerative disc disease (DDD), degenerative spondylolisthesis, or spinal stenosis, or
   • Any number of lumbar and/or lumbosacral levels for degenerative scoliosis (defined as >10º coronal curve) or sagittal deformity

5. Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria:

   • 1-2 levels treated for DDD, and
   • 3 or 4 interfixated screws placed, and
   • Implant lordosis is ≤20°

Exclusion Criteria:

1. Patient was a prisoner at the time of Modulus ALIF treatment
2. Patient was participating in another clinical study during treatment 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	Intervention / Treatment
Modulus ALIF System	Device: Modulus ALIF System; The Modulus ALIF System is designed to address lumbar pathologies utilizing interbody placement through an anterior or anterolateral surgical approach. The Modulus ALIF System is an interfixated interbody system available in various shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rates of complications attributable to the use of the Modulus ALIF System	12 months
Proportion of subjects with apparent radiographic fusion at 6 months or greater postoperative	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Actual): October 15, 2022
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): 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; Pathological Conditions, Anatomical; Spinal Diseases; Spondylolysis; Spondylosis; Pathological Conditions, Signs and Symptoms; Constriction, Pathologic; Spondylolisthesis; Intervertebral Disc Degeneration
• Other Study ID Numbers: NUVA.RMA0222

Drug and device information, study documents

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