MOTUS Total Joint Replacement Investigational Device Exemption Study

Lumbar Spine Degeneration Clinical Trial

Official title:

An Interventional, Multi-center Investigation of the MOTUS Total Joint Replacement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05438719
• Other study ID #: MOTUS IDE
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: June 20, 2028

Study information

• Verified date: June 2024
• Source: 3Spine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 158
• Est. completion date: June 20, 2028
• Est. primary completion date: June 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Spine Degeneration

Intervention

Device:
• MOTUS Total Joint Replacement
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.

Locations

Country	Name	City	State
United States	Center for Sports Medicine and Orthopaedics	Chattanooga	Tennessee
United States	Spine an Orthopedic Center	Deerfield Beach	Florida
United States	Upstate Ortho	East Syracuse	New York
United States	Todd H. Lanman, MD Inc.	Los Angeles	California
United States	NYU Langone	New York	New York
United States	Oklahoma Spine Center	Oklahoma City	Oklahoma
United States	Strenge Spine Institute	Paducah	Kentucky
United States	Pinehurst Surgical Clinic	Pinehurst	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Orthopedic San Antonio	San Antonio	Texas
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Steamboat Orthopaedic & Spine Institute (SOSI)	Steamboat Springs	Colorado
United States	Florida Orthopaedic Institute	Temple Terrace	Florida
United States	The Disc Replacement Center	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
3Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-Reported Outcomes Measurement Information System (PROMIS)	Improvement in PROMIS scores at 24 months relative to the baseline.	24 months
Other	Demographics	The study will examine the patient population through descriptive statistics of the demographic variable - age	24 months
Other	Demographics	The study will examine the patient population through descriptive statistics of the demographic variable - Body Mass Index (BMI)	24 months
Other	Demographics	The study will examine the patient population through descriptive statistics of the demographic variable - gender	24 months
Other	Intra-Operative Variables	The study will examine the patient population through descriptive statistics of the intra-operative variable - surgery time.	24 months
Other	Intra-Operative Variables	The study will examine the patient population through descriptive statistics of the intra-operative variable - blood loss	24 months
Other	Time to first SSI	Time to first SSI including specific actions (removal, revision, replacement, supplemental fixation) at the index or adjacent level	24 months
Primary	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.	24 months compared to baseline
Primary	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).	24 months compared to baseline
Primary	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.	24 month
Primary	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).	24 month
Secondary	Visual Analog Score (VAS) - Worst Leg	Improvement in VAS - Worst leg of 20mm at 24 months compared to baseline	24 months
Secondary	VAS - Back	Improvement in VAS - Back pain of 20mm at 24 months compared to baseline	24 months
Secondary	ODI	Improvement in ODI of 15 points at 24 months compared to baseline	24 months
Secondary	ODI	Mean change in ODI over time intervals	24 months
Secondary	VAS	Mean change in leg VAS over time intervals	24 months
Secondary	VAS	Mean change in back VAS over time intervals	24 months
Secondary	Radiographically confirmed subsidence	Absence of radiographically confirmed subsidence >5mm	24 months