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Status:

ENROLLING_BY_INVITATION

Lumbar Interbody Implant Study

Lead Sponsor:

NuVasive

Conditions:

Degenerative Disc Disease

Degenerative Spondylolisthesis

Eligibility:

All Genders

18+ years

Brief Summary

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, radiog...

Detailed Description

This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select interbody implant devices in patients who undergo interbody fusion surgery. Consecutive pa...

Eligibility Criteria

Inclusion

  • 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)
  • NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the thoracolumbar spine (unless the interbody device to be used is interfixated and is cleared by the regulatory body to be used standalone)
  • Able to undergo surgery based on physical exam, medical history, and surgeon judgment
  • Understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 1 2026

Estimated Enrollment :

1050 Patients enrolled

Trial Details

Trial ID

NCT04418830

Start Date

October 1 2020

End Date

July 1 2026

Last Update

December 22 2025

Active Locations (16)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (16 locations)

1

University of California San Diego

La Jolla, California, United States, 92037

2

Verma Spine

Los Alamitos, California, United States, 90720

3

Valley Spine Care

Merced, California, United States, 95348

4

Hoag Orthopedics

Orange, California, United States, 92868