Retrospective Modulus ALIF Study

Completed

Conditions studied: Degenerative Disc Disease, Spondylolisthesis, Stenosis

In brief

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.

Key facts

Study ID

NCT05566704

Run by

NuVasive

People needed

123

Starts

2022-08-18

Expected to finish

2024-05-01

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• 1-2 levels treated for DDD, and
• 3 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

Where it is running

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

Full record on ClinicalTrials.gov

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