Modulus in XLIF Study

NCT04418817 | Completed

• 1 other identifier: NUVA.X1901
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Degenerative Disc Disease; Degenerative Spondylolisthesis; Degenerative Scoliosis

Outcome Measures

Primary Outcomes (2)

• Rate of Complications

  Rate of complications attributable to use of the Modulus XLIF interbody implant

  At least 12 months

• Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative

  Proportion of subjects with fusion at 12 months or greater

  At least 12 months

Secondary Outcomes (1)

• Improvement in neurologic status

  At least 12 months

Study Arms (1)

Modulus XLIF Interbody System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 asked to consent to participate in the study. Once enrolled in the study, subjects will undergo a computed tomography (CT) scan at 12 months postoperative or later to evaluate their fusion status.

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

Sponsors & Collaborators

• NuVasive: lead

Study Sites (2)

Erik C. Spayde, MD Inc.

Thousand Oaks, California, 91360, United States

Location

Georgia Spine & Neurosurgery Center

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Kyle Malone, MS

  NuVasive

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: March 22, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (2)