XLIF Decade Plate System Study (NCT04689880) | Clinical Trial Compass
CompletedNot Applicable
XLIF Decade Plate System Study
United States75 participantsStarted 2021-04-12
Plain-language summary
The primary objective of this study is to evaluate the safety and performance of the NuVasive XLIF Decade Plate System as measured by patient-reported outcomes (PROs), radiographic outcomes, and reported complications.
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 interbody fusion surgery using the Decade Plate System in conjunction with an interbody implant to treat one or two levels in the thoracic and/or lumbar spine for
✓. degenerative disc disease
✓. spondylolisthesis
✓. scoliosis, kyphosis, lordosis
✓. spinal stenosis
✓. spondylolysis
✓. pseudoarthrosis or failed previous spine surgery
Exclusion criteria
✕. Use of posterior fixation for the scheduled surgery Note: Should the surgical plan change intraoperatively and posterior fixation is used in the case, the participant will be withdrawn from the study
✕. 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 materials implanted
✕. Systemic or local infection (latent or active) or signs of local inflammation
✕. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
✕. Pregnant, or plans to become pregnant during the study