Clinical trial NCT05438719: MOTUS Total Joint Replacement Investigational Device Exemption Study
Official title: An Interventional, Multi-center Investigation of the MOTUS Total Joint Replacement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lumbar Spine Degeneration
Lead sponsor: 3Spine
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 158
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy
2. 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:

   1. Herniated nucleus pulposus
   2. Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule
   3. Facet joint degeneration/osteophyte formation
   4. Spondylosis (defined by the presence of osteophytes)
   5. Disc degeneration and/or annular degeneration; and/or
   6. Lumbar stenosis defined by spinal cord or nerve root compression
3. 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
4. Preoperative Oswestry Disability Index score ≥ 40/100 at baseline
5. 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
6. Signed informed consent.

Exclusion Criteria:

1. More than one vertebral level requiring treatment
2. Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level
3. Degenerative or lytic spondylolisthesis greater than Grade 1 (25% translation)
4. Rotatory scoliosis at the index level
5. Congenital bony and/or spinal cord abnormalities at the index level
6. Subcaudal defect, disrupting the integrity of the pedicle
7. 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
8. Disrupted anterior longitudinal ligament at the index level
9. Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated
10. Back pain of unknown etiology without leg pain
11. Severe spondylosis at the level to be treated as characterized by any of the following:

    1. Autofusion (solid arthrodesis) determined radiographically (CT)
    2. Totally collapsed disc, or
    3. Vertebral body that cannot be mobilized
12. Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or vitamin E
13. Unable to undergo an MRI scan, CT scan or other radiograph assessments
14. 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;
15. 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)
16. Insulin-dependent diabetes mellitus
17. Lactating, pregnant or interested in becoming pregnant in the next 3 years
18. Active infection - systemic or local
19. 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
20. Body Mass Index \> 40
21. Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease
22. 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
23. Spinal tumor
24. 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
25. 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
26. Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease
27. Has a Waddell Signs of Inorganic Behavior score of 3 or greater
28. 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
29. Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 (Diagnostic and Statistical Manual) code
30. Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping) (Use within 30 days of surgery date is considered 'current')
31. Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation
32. Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results
33. 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.

Primary outcomes:
measure: Oswestry Disability Index (ODI) Score
timeFrame: 24 months compared to baseline
measure: Neurological Status
timeFrame: 24 months compared to baseline
measure: Secondary Surgical Intervention (SSI)
timeFrame: 24 month
measure: Serious device-related adverse events (SDAE)
timeFrame: 24 month
Secondary outcomes:
measure: Visual Analog Score (VAS) - Worst Leg
timeFrame: 24 months
measure: VAS - Back
timeFrame: 24 months
measure: ODI
timeFrame: 24 months
measure: ODI
timeFrame: 24 months
measure: VAS
timeFrame: 24 months
measure: VAS
timeFrame: 24 months
measure: Radiographically confirmed subsidence
timeFrame: 24 months
Other outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 24 months
measure: Demographics
timeFrame: 24 months
measure: Demographics
timeFrame: 24 months
measure: Demographics
timeFrame: 24 months
measure: Intra-Operative Variables
timeFrame: 24 months
measure: Intra-Operative Variables
timeFrame: 24 months
measure: Time to first SSI
timeFrame: 24 months
Locations:
city: Los Angeles
country: United States
facility: Todd H. Lanman, MD Inc.
state: California
city: Steamboat Springs
country: United States
facility: Steamboat Orthopaedic & Spine Institute (SOSI)
state: Colorado
city: Deerfield Beach
country: United States
facility: Spine an Orthopedic Center
state: Florida
city: Temple Terrace
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Paducah
country: United States
facility: Strenge Spine Institute
state: Kentucky
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: East Syracuse
country: United States
facility: Upstate Ortho
state: New York
city: New York
country: United States
facility: NYU Langone
state: New York
city: Pinehurst
country: United States
facility: Pinehurst Surgical Clinic
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Spine Center
state: Oklahoma
city: Chattanooga
country: United States
facility: Center for Sports Medicine and Orthopaedics
state: Tennessee
city: San Antonio
country: United States
facility: Orthopedic San Antonio
state: Texas
city: West Jordan
country: United States
facility: The Disc Replacement Center
state: Utah
Study officials:
References: