MOTUS Total Joint Replacement Investigational Device Exemption Study (NCT05438719) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MOTUS Total Joint Replacement Investigational Device Exemption Study
United States158 participantsStarted 2022-06-23
Plain-language summary
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.
Who can participate
Age range21 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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)
✓. Lumbar stenosis defined by spinal cord or nerve root compression
Exclusion criteria
✕. More than one vertebral level requiring treatment
✕. Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level
✕. Degenerative or lytic spondylolisthesis greater than Grade 1 (25% translation)
✕. Congenital bony and/or spinal cord abnormalities at the index level
✕. Subcaudal defect, disrupting the integrity of the pedicle
✕. Clinically compromised vertebral bodies at the index level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, malunion or nonunion
✕. Disrupted anterior longitudinal ligament at the index level