An Interventional, Multi-center Investigation of the MOTUS Total Joint Replacement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Spine Degeneration
- Sponsor
- 3Spine
- Enrollment
- 158
- Locations
- 14
- Primary Endpoint
- Neurological Status
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
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)
- •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
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)
- •Rotatory scoliosis at the index level
- •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
- •Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated
- •Back pain of unknown etiology without leg pain
Outcomes
Primary Outcomes
Neurological Status
Time Frame: 24 months compared to baseline
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).
Secondary Surgical Intervention (SSI)
Time Frame: 24 month
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.
Oswestry Disability Index (ODI) Score
Time Frame: 24 months compared to baseline
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.
Serious device-related adverse events (SDAE)
Time Frame: 24 month
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).
Secondary Outcomes
- Visual Analog Score (VAS) - Worst Leg(24 months)
- VAS - Back(24 months)
- ODI(24 months)
- VAS(24 months)
- Radiographically confirmed subsidence(24 months)