NCT05566704

Retrospective Modulus ALIF Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 123 (actual)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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

Conditions

• Degenerative Disc Disease
• Spondylolisthesis
• Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-18
• Primary completion: 2022-10-15
• Completion: 2024-05-01
• First posted: 2022-10-04
• Last updated: 2025-12-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study