MOTUS Total Joint Replacement Investigational Device Exemption Study

Not Applicable

Active, not recruiting

• Conditions: Lumbar Spine Degeneration
• Interventions: Device: MOTUS Total Joint Replacement

• Registration Number: NCT05438719
• Lead Sponsor: 3Spine

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.

Study Timeline

• Study Start: 2022-06-20
• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26
• Primary Completion: 2026-06-13
• Study Completion: 2029-06-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MOTUS	MOTUS Total Joint Replacement	All subjects will be treated with the MOTUS Total Joint Replacement

Primary Outcome Measures

Name	Time	Method
Neurological Status	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)	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	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)	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 Outcome Measures

Name	Time	Method
Visual Analog Score (VAS) - Worst Leg	24 months	Improvement in VAS - Worst leg of 20mm at 24 months compared to baseline
VAS - Back	24 months	Improvement in VAS - Back pain of 20mm at 24 months compared to baseline
ODI	24 months	Mean change in ODI over time intervals
VAS	24 months	Mean change in back VAS over time intervals
Radiographically confirmed subsidence	24 months	Absence of radiographically confirmed subsidence \>5mm

Trial Locations

Locations (14)

Florida Orthopaedic Institute; 🇺🇸 Temple Terrace, Florida, United States

Strenge Spine Institute; 🇺🇸 Paducah, Kentucky, United States

Spine Institute of Louisiana; 🇺🇸 Shreveport, Louisiana, United States

Upstate Ortho; 🇺🇸 East Syracuse, New York, United States

Steamboat Orthopaedic & Spine Institute (SOSI); 🇺🇸 Steamboat Springs, Colorado, United States

NYU Langone; 🇺🇸 New York, New York, United States

Center for Sports Medicine and Orthopaedics; 🇺🇸 Chattanooga, Tennessee, United States

The Disc Replacement Center; 🇺🇸 West Jordan, Utah, United States

Todd H. Lanman, MD Inc.; 🇺🇸 Los Angeles, California, United States

Spine an Orthopedic Center; 🇺🇸 Deerfield Beach, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Pinehurst Surgical Clinic; 🇺🇸 Pinehurst, North Carolina, United States

Oklahoma Spine Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Orthopedic San Antonio; 🇺🇸 San Antonio, Texas, United States