BalancedBack Total Joint Replacement Investigational Device Exemption Study

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

Sponsors

Lead Sponsor: 3Spine

Source 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 (BalancedBack 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 BalancedBack 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.

Overall Status Recruiting
Start Date 2022-06-20
Completion Date 2028-06-20
Primary Completion Date 2025-06-20
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Oswestry Disability Index (ODI) Score 24 months compared to baseline
Neurological Status 24 months compared to baseline
Secondary Surgical Intervention (SSI) 24 month
Serious device-related adverse events (SDAE) 24 month
Secondary Outcome
Measure Time Frame
Visual Analog Score (VAS) - Worst Leg 24 months
VAS - Back 24 months
ODI 24 months
ODI 24 months
VAS 24 months
VAS 24 months
Radiographically confirmed subsidence 24 months
Enrollment 158
Condition
Intervention

Intervention Type: Device

Intervention Name: BalancedBack Total Joint Replacement

Description: The BalancedBack 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.

Arm Group Label: BalancedBack

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 to screen if a DEXA (dual energy x-ray absorptiometry) scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required. 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 screening 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.

Gender:

All

Minimum Age:

21 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Kevin McGinnis

Phone: 781-291-8040

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Center for Sports Medicine and Orthopaedics Danette Newton 423-634-2696 [email protected] Benjamin Geddes, MD Principal Investigator
Location Countries

United States

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: BalancedBack

Type: Experimental

Description: All subjects will be treated with the BalancedBack Total Joint Replacement

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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