BalancedBack Total Joint Replacement Investigational Device Exemption Study

• ClinicalTrials.gov Identifier: NCT05438719
• Recruitment Status: Recruiting
• First Posted: June 30, 2022
• Last Update Posted: February 16, 2023
• Sponsor: 3Spine
• Information provided by (Responsible Party): 3Spine

Tracking Information

• First Submitted Date: June 22, 2022
• First Posted Date: June 30, 2022
• Last Update Posted Date: February 16, 2023
• Actual Study Start Date: June 20, 2022
• Estimated Primary Completion Date: June 20, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 27, 2022)

• Oswestry Disability Index (ODI) Score [ Time Frame: 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.
• Neurological Status [ Time Frame: 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) [ Time Frame: 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.
• Serious device-related adverse events (SDAE) [ Time Frame: 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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 27, 2022)

• Visual Analog Score (VAS) - Worst Leg [ Time Frame: 24 months ]
  Improvement in VAS - Worst leg of 20mm at 24 months compared to baseline
• VAS - Back [ Time Frame: 24 months ]
  Improvement in VAS - Back pain of 20mm at 24 months compared to baseline
• ODI [ Time Frame: 24 months ]
  Improvement in ODI of 15 points at 24 months compared to baseline
• ODI [ Time Frame: 24 months ]
  Mean change in ODI over time intervals
• VAS [ Time Frame: 24 months ]
  Mean change in leg VAS over time intervals
• VAS [ Time Frame: 24 months ]
  Mean change in back VAS over time intervals
• Radiographically confirmed subsidence [ Time Frame: 24 months ]
  Absence of radiographically confirmed subsidence >5mm

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 27, 2022)

• Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 24 months ]
  Improvement in PROMIS scores at 24 months relative to the baseline.
• Demographics [ Time Frame: 24 months ]
  The study will examine the patient population through descriptive statistics of the demographic variable - age
• Demographics [ Time Frame: 24 months ]
  The study will examine the patient population through descriptive statistics of the demographic variable - Body Mass Index (BMI)
• Demographics [ Time Frame: 24 months ]
  The study will examine the patient population through descriptive statistics of the demographic variable - gender
• Intra-Operative Variables [ Time Frame: 24 months ]
  The study will examine the patient population through descriptive statistics of the intra-operative variable - surgery time.
• Intra-Operative Variables [ Time Frame: 24 months ]
  The study will examine the patient population through descriptive statistics of the intra-operative variable - blood loss
• Time to first SSI [ Time Frame: 24 months ]
  Time to first SSI including specific actions (removal, revision, replacement, supplemental fixation) at the index or adjacent level

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: BalancedBack Total Joint Replacement Investigational Device Exemption Study
• Official Title: An Interventional, Multi-center Investigation of the BalancedBack Total Joint Replacement
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lumbar Spine Degeneration

Intervention

Device: BalancedBack Total Joint Replacement

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.

Study Arms

Experimental: BalancedBack

All subjects will be treated with the BalancedBack Total Joint Replacement

Intervention: Device: BalancedBack Total Joint Replacement

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 27, 2022): 158
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 20, 2028
• Estimated Primary Completion Date: June 20, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kevin McGinnis; 781-291-8040; kevin.mcginnis@3spine.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05438719
• Other Study ID Numbers: BalancedBack IDE
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: 3Spine
• Original Responsible Party: Same as current
• Current Study Sponsor: 3Spine
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: 3Spine
• Verification Date: February 2023