Lumbar Interbody Implant Study

Enrolling by invitation

Conditions studied: Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis, Sagittal Deformity

In brief

The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and patient-reported outcomes. This study is being undertaken to identify possible residual risks and to clarify mid- to long-term clinical performance that may affect the benefit/risk ratios of these interbody implants.

Key facts

Study ID

NCT04418830

Run by

NuVasive

People needed

1050

Starts

2020-10-01

Expected to finish

2026-07-01

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…

• Patients who are ≥18 years of age at the time of consent
• Planned spine surgery using interbody implants at:
• One or two adjacent thoracic, lumbar, and/or lumbosacral levels for degenerative disc disease or degenerative spondylolisthesis, or
• One or two adjacent thoracic, lumbar, and/or lumbosacral levels for spinal stenosis (not applicable for MLX, TLX, or XLX ACR), or
• Any number of thoracic, lumbar, and/or lumbosacral levels for degenerative scoliosis (defined as >10º coronal curve), or
• Any number of thoracic, lumbar, and/or lumbosacral levels for sagittal deformity (not applicable for MLX, TLX, or XLX ACR).
• Use of one of the following implants (NuVasive, Inc., San Diego, CA):
• Base Interfixated
• Brigade Interfixated
• Coalesce Thoracolumbar
• Cohere TLIF
• Cohere XLIF
• Coroent Ti PLIF
• Coroent Ti TLIF
• Coroent Ti XLIF
• MLX
• Modulus ALIF
• Modulus TLIF
• Modulus XLIF
• TLX
• XLX ACR
• Interbody fusion with one or more of the following (as allowed by implant type):
• autograft
• allograft (i.e., cancellous and/or corticocancellous allograft bone)
• Attrax Putty (NuVasive) (not applicable for MLX, TLX, or XLX ACR)

You may not qualify if…

• Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include:
• Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic))
• Synthetic bone graft extenders (e.g., Attrax Scaffold (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 level(s) to be treated (adjacent level surgery is acceptable; prior decompression is acceptable)
• Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
• Use of bone growth stimulators postoperatively
• Active smoking within 6 weeks before surgery
• Patient has known sensitivity to the materials implanted
• Systemic or local infection (latent or active) or signs of local inflammation
• Patient has inadequate bone stock or bone quality, or a physical or medical condition that would prohibit beneficial surgical outcomes based on surgeon judgment
• Patient is a prisoner
• Patient is participating in another clinical study that would confound study data

Where it is running

• University of California San Diego — La Jolla, California, United States
• Verma Spine — Los Alamitos, California, United States
• Valley Spine Care — Merced, California, United States
• Hoag Orthopedics — Orange, California, United States
• Hartford Healthcare Bone and Joint Institute — Hartford, Connecticut, United States
• Lyerly Neurosurgery — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• DuPage Medical Group — Naperville, Illinois, United States
• Beaumont Hospital Research Institute — Royal Oak, Michigan, United States
• Columbia Orthopaedics Group — Columbia, Missouri, United States
• Duke University — Durham, North Carolina, United States
• Atlantic Brain and Spine — Wilmington, North Carolina, United States
• Summa Health — Akron, Ohio, United States
• Ohio State University — Dublin, Ohio, United States
• UPMC Presbyterian — Pittsburgh, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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