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.
A multi-center (up to 20 investigational sites), prospective, non-blinded investigation of the MOTUS Total Joint Replacement (TJR) device. These data will be compared to a lumbar interbody fusion (transforaminal lumbar interbody fusion \[TLIF\] or posterior lumbar interbody fusion \[PLIF\]) control group enrolled in a separate real world evidence (RWE) study. Balance between groups will be achieved through sub classification using propensity scores by a blinded statistician.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
158
The MOTUS Total Joint Replacement is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1 for skeletally mature patients due to symptomatic lumbar degeneration with or without foraminal or recess spinal stenosis confirmed by radiographic imaging (CT, MRI, X-rays), with no more than a Grade 1 spondylolisthesis at the involved level.
Todd H. Lanman, MD Inc.
Los Angeles, California, United States
Steamboat Orthopaedic & Spine Institute (SOSI)
Steamboat Springs, Colorado, United States
Spine an Orthopedic Center
Oswestry Disability Index (ODI) Score
Improvement of at least 15 points in ODI score (out of 100). The ODI is a self-reported questionnaire that contains ten sections concerning intensity of pain, lifting, personal care, walking, sitting, sexual function, standing, social life, sleeping and traveling.
Time frame: 24 months compared to baseline
Neurological Status
Absence of deterioration in neurological status compared to baseline examinations. Neurological examination will consist of a motor and sensory examination at each in person study visit conducted per physician standard of care. These data will be adjudicated by the Clinical Events Committee (CEC).
Time frame: 24 months compared to baseline
Secondary Surgical Intervention (SSI)
Subject success will be determined with the absence of a secondary surgical intervention including revision, re-operation, removal, or supplemental fixation at the index level.
Time frame: 24 month
Serious device-related adverse events (SDAE)
Subject success will be determined with the absence of any serious device-related adverse events (SDAE). These data will be adjudicated by the Clinical Events Committee (CEC).
Time frame: 24 month
Visual Analog Score (VAS) - Worst Leg
Improvement in VAS - Worst leg of 20mm at 24 months compared to baseline
Time frame: 24 months
VAS - Back
Improvement in VAS - Back pain of 20mm at 24 months compared to baseline
Time frame: 24 months
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Deerfield Beach, Florida, United States
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Temple Terrace, Florida, United States
Strenge Spine Institute
Paducah, Kentucky, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Upstate Ortho
East Syracuse, New York, United States
NYU Langone
New York, New York, United States
Pinehurst Surgical Clinic
Pinehurst, North Carolina, United States
...and 4 more locations
ODI
Improvement in ODI of 15 points at 24 months compared to baseline
Time frame: 24 months
ODI
Mean change in ODI over time intervals
Time frame: 24 months
VAS
Mean change in leg VAS over time intervals
Time frame: 24 months
VAS
Mean change in back VAS over time intervals
Time frame: 24 months
Radiographically confirmed subsidence
Absence of radiographically confirmed subsidence \>5mm
Time frame: 24 months