Status:
COMPLETED
Modulus in XLIF Study
Lead Sponsor:
NuVasive
Conditions:
Degenerative Disc Disease
Degenerative Spondylolisthesis
Eligibility:
All Genders
18+ years
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 rep...
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 eligib...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04418817
Start Date
March 22 2020
End Date
January 31 2024
Last Update
December 22 2025
Active Locations (2)
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1
Erik C. Spayde, MD Inc.
Thousand Oaks, California, United States, 91360
2
Georgia Spine & Neurosurgery Center
Atlanta, Georgia, United States, 30342