Lumbar Interbody Implant Study (NCT04418830) | Clinical Trial Compass
By InvitationNot Applicable
Lumbar Interbody Implant Study
United States1,050 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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))
. 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)