Retrospective Modulus ALIF Study

NCT05566704 | Completed FDA Device

• 1 other identifier: NUVA.RMA0222
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Degenerative Disc Disease; Spondylolisthesis; Stenosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available

  12 months

Study Arms (1)

Modulus ALIF System

Device: Modulus ALIF System

Interventions

Modulus ALIF System DEVICE

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.

Modulus ALIF System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery
• Male or female patients who are ≥18 years of age at the time of surgery
• 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
• 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
• Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria:
• levels treated for DDD, and
• or 4 interfixated screws placed, and
• Implant lordosis is ≤20°

You may not qualify if:

• Patient was a prisoner at the time of Modulus ALIF treatment
• Patient was participating in another clinical study during treatment that would confound study data

Sponsors & Collaborators

• NuVasive: lead

Study Sites (5)

Hoag Orthopedics

Orange, California, 92868, United States

Location

Girard Orthopedic Surgeons

San Diego, California, 92121, United States

Location

Georgia Spine & Neurosurgery Center

Atlanta, Georgia, 30342, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Atlantic Brain and Spine

Wilmington, North Carolina, 28401, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyle Malone, MS

  Globus Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: August 18, 2022
• Primary Completion: October 15, 2022
• Study Completion: May 1, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (5)