Modulus in XLIF Study

Completed

Conditions studied: Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis

In brief

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.

Key facts

Study ID

NCT04418817

Run by

NuVasive

People needed

36

Starts

2020-03-22

Expected to finish

2024-01-31

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…

• Male or female patients who are ≥18 years of age at the time of surgery
• Treated with XLIF procedure with the Modulus 3D-printed titanium interbody implant at:
• One or two thoracic and/or lumbar levels for degenerative disc disease or degenerative spondylolisthesis, or
• Any number of thoracic and/or lumbar levels for degenerative scoliosis (defined as >10º coronal curve)
• Interbody fusion with autograft and/or allograft
• Any NuVasive supplemental fixation
• 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.
• Patient understands the conditions of enrollment and is willing to sign an informed consent form to participate.

You may not qualify if…

• 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:
• Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic))
• 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))
• 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))
• Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
• Previous lumbar fusion surgery at the currently treated level(s) (adjacent-level surgery is acceptable)
• Patients with active infection at the surgical site at the time of surgery
• Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
• Patient is unwilling or unable to undergo a CT scan due to pregnancy or other medical condition
• Patient is a prisoner
• Patient is participating in another clinical study that would confound study data

Where it is running

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

Full record on ClinicalTrials.gov

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