Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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, 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.

Official Title

A Prospective, Multicenter Study Evaluating the Safety and Performance of Interbody Implants for the Treatment of Patients With Degenerative Conditions of the Thoracic and/or Lumbar Spine

Details

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 patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with degenerative conditions in the thoracic and/or lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled into the study, subjects will undergo interbody fusion surgery using one of the NuVasive interbody implant groups based on the surgeon's standard of care. At least 1050 subjects (a minimum of 75 patients in each implant group) will be enrolled and will be followed for 24 months after the surgery.

Keywords

Degenerative Disc Disease Degenerative Spondylolisthesis Degenerative Scoliosis Spinal Stenosis Sagittal Deformity Spine Surgery Medical Device Scoliosis Intervertebral Disc Degeneration Spondylolisthesis Base Interfixated System Brigade Interfixated System Coalesce Thoracolumbar Interbody Cohere XLIF Interbody System CoRoent Ti PLIF Interbody System CoRoent Ti TLIF Interbody System MLX - Medial Lateral Expandable Interbody System Modulus TLIF Interbody System Modulus XLIF Interbody System TLX Interbody System XLX ACR Interbody System CoRoent Ti XLIF Interbody System Cohere TLIF Modulus ALIF

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patients who are ≥18 years of age at the time of consent
  2. Planned spine surgery using interbody implants at:
  3. One or two adjacent thoracic, lumbar, and/or lumbosacral levels for degenerative disc disease or degenerative spondylolisthesis, or
  4. One or two adjacent thoracic, lumbar, and/or lumbosacral levels for spinal stenosis (not applicable for MLX, TLX, or XLX ACR), or
  5. Any number of thoracic, lumbar, and/or lumbosacral levels for degenerative scoliosis (defined as >10º coronal curve), or
  6. Any number of thoracic, lumbar, and/or lumbosacral levels for sagittal deformity (not applicable for MLX, TLX, or XLX ACR).
  7. Use of one of the following implants (NuVasive, Inc., San Diego, CA):
  8. Base Interfixated
  9. Brigade Interfixated
  10. Coalesce Thoracolumbar
  11. Cohere TLIF
  12. Cohere XLIF
  13. Coroent Ti PLIF
  14. Coroent Ti TLIF
  15. Coroent Ti XLIF
  16. MLX
  17. . Modulus ALIF
  18. . Modulus TLIF
  19. . Modulus XLIF
  20. . TLX
  21. . XLX ACR
  22. Interbody fusion with autograft and/or allograft (i.e., cancellous and/or corticocancellous allograft bone)
  23. 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)
  24. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
  25. 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

You CAN'T join if...

  1. Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include:
  2. Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic))
  3. 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))
  4. 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))
  5. Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
  6. Previous lumbar fusion surgery at the level(s) to be treated (adjacent level surgery is acceptable; prior decompression is acceptable)
  7. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
  8. Use of bone growth stimulators postoperatively
  9. Active smoking within 6 weeks before surgery
  10. Patient has known sensitivity to the materials implanted
  11. Systemic or local infection (latent or active) or signs of local inflammation
  12. Patient has inadequate bone stock or bone quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
  13. Patient is a prisoner
  14. . Patient is participating in another clinical study that would confound study data

Locations

  • University of California San Diego
    La Jolla California 92037 United States
  • Columbia Orthopaedics Group
    Columbia Missouri 65201 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
NuVasive
ID
NCT04418830
Study Type
Observational
Last Updated