Status:
ACTIVE_NOT_RECRUITING
MOTUS Total Joint Replacement Investigational Device Exemption Study
Lead Sponsor:
3Spine
Conditions:
Lumbar Spine Degeneration
Eligibility:
All Genders
21-80 years
Phase:
NA
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 Replacem...
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 (tra...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Severe spondylosis at the level to be treated as characterized by any of the following:
- Autofusion (solid arthrodesis) determined radiographically (CT)
- Totally collapsed disc, or
- Vertebral body that cannot be mobilized
- Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or vitamin E
- Unable to undergo an MRI scan, CT scan or other radiograph assessments
- Osteopenia: The SCORE/MORES will be utilized for all females age \<50 and males age \<55 to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required. A DEXA scan is indicated for all females age ≥50 and all males age ≥55. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score ≤ -1. An existing DEXA is allowed if completed within 6 months of subject screening;
- Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g.: Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis imperfecta)
- Insulin-dependent diabetes mellitus
- Lactating, pregnant or interested in becoming pregnant in the next 3 years
- Active infection - systemic or local
- Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study
- Body Mass Index \> 40
- Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease
- Systemic disease including Lupus disease, Reiter's disease, Rheumatoid disease, AIDS, HIV, hepatitis or autoimmune disease that requires immunosuppressive therapy, including biologics, for systemic inflammation
- Spinal tumor
- Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
- Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis
- Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease
- Has a Waddell Signs of Inorganic Behavior score of 3 or greater
- In the opinion of the investigator, the subject has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device
- Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 (Diagnostic and Statistical Manual) code
- Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping) (Use within 30 days of surgery date is considered 'current')
- Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation
- Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results
- Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2029
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05438719
Start Date
June 23 2022
End Date
June 13 2029
Last Update
December 3 2025
Active Locations (14)
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1
Todd H. Lanman, MD Inc.
Los Angeles, California, United States, 90210
2
Steamboat Orthopaedic & Spine Institute (SOSI)
Steamboat Springs, Colorado, United States, 80487
3
Spine an Orthopedic Center
Deerfield Beach, Florida, United States, 33441
4
Florida Orthopaedic Institute
Temple Terrace, Florida, United States, 33637