Modulus in XLIF Study (NCT04418817) | Clinical Trial Compass
CompletedNot Applicable
Modulus in XLIF Study
United States36 participantsStarted 2020-03-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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))
✕. 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)