The objective of this study is to evaluate the safety and performance of thoracic and/or lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported complications, radiographic outcomes, and clinical patient 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 the MLX and XLX ACR interbody implants.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients who were ≥18 years of age at the time of surgery
✓. Underwent spine surgery using either MLX or XLX ACR interbody implant (NuVasive, Inc., San Diego, CA) at:
✓. One or two adjacent thoracic and/or lumbar levels for degenerative disc disease or degenerative spondylolisthesis, or
✓. Any number of thoracic and/or lumbar levels for degenerative scoliosis (defined as \>10º coronal curve)
✕. 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))
What they're measuring
1
Rate of Complications
Timeframe: At least three months
2
Proportion of Subjects with Improvement in Neurological Symptoms
✕. Previous lumbar fusion surgery at the currently treated level(s) (adjacent-level surgery is acceptable)
✕. Systemic or local infection (latent or active) or signs of local inflammation documented at the time of surgery
✕. Patient was involved in active litigation relating to the spine during the surgical/postoperative period (worker's compensation claim is allowed if it is not contested)