A selective (non-comprehensive) list of some of the more relevant inclusion/exclusion criteria for the study
Inclusion criteria |
Age 18–60 y |
Symptomatic lumbar degenerative disease: magnetic resonance imaging–confirmed disc desiccation, loss of disc height, and bridging osteophytes |
Symptomatic level L1-2, L2-3, L3-4, or L4-5 |
Preoperative Oswestry Disability Index score ≥ 30 points |
Unresponsive to conservative treatment for > 6 mo or presence of progressive neurologic symptoms |
Willing and able to comply with requirements defined in protocol for duration of study |
Signed and dated informed consent form |
Exclusion criteria |
Prior lumbar fusion surgery at operative level |
Prior lumbar laminectomy at operative level |
Prior complete lumbar facetectomy at operative level |
Prior bilateral retroperitoneal surgery |
Radiographic signs of significant instability at operative level (> 3-mm translation, > 11° angulation different from adjacent level) |
Bridging osteophytes or absence of motion < 2° |
Radiographic confirmation of significant facet joint disease or degeneration |
Pars defect, facet abnormality, or other compromise of posterior elements |
Spondylolisthesis (greater than grade 1) |
Osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated |
Body mass index > 40 |
Active local or systemic infection, including AIDS and hepatitis |