An Interventional, Multi-center Investigation of the MOTUS Total Joint Replacement
This study is designed to collect safety and efficacy data on patients who plan to undergo a single-level total joint replacement of the lumbar spine using the MOTUS device (MOTUS Total Joint Replacement procedure) to demonstrate noninferiority to lumbar interbody fusion with respect to composite endpoints.
• Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy
• The subject has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar spine at a single level from L1/L2 to L5/S1 confirmed by subject history and radiographic imaging (CT, MRI, X- rays) with no more than a Grade 1 (\<25% translation) spondylolisthesis. Symptomatic lumbar degeneration that may be associated with a co-morbid condition such as:
‣ Herniated nucleus pulposus
⁃ Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule
⁃ Facet joint degeneration/osteophyte formation
⁃ Spondylosis (defined by the presence of osteophytes)
⁃ Disc degeneration and/or annular degeneration; and/or
⁃ Lumbar stenosis defined by spinal cord or nerve root compression
• Exhausted conservative treatment (e.g. bed rest, physical therapy, medications, TENS (transcutaneous electrical nerve stimulation), manipulation, and/or spinal injections) for at least 3 months or has a neurologic emergency
• Preoperative Oswestry Disability Index score ≥ 40/100 at baseline
• Psychosocially, mentally, and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms
• Signed informed consent.