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BalancedBack Total Joint Replacement Investigational Device Exemption Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05438719
Recruitment Status : Recruiting
First Posted : June 30, 2022
Last Update Posted : February 6, 2023
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lumbar Spine Degeneration Device: BalancedBack Total Joint Replacement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Interventional, Multi-center Investigation of the BalancedBack Total Joint Replacement
Actual Study Start Date : June 20, 2022
Estimated Primary Completion Date : June 20, 2025
Estimated Study Completion Date : June 20, 2028

Arm Intervention/treatment
Experimental: BalancedBack
All subjects will be treated with the BalancedBack Total Joint Replacement
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.




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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).


Secondary Outcome Measures :
  1. Visual Analog Score (VAS) - Worst Leg [ Time Frame: 24 months ]
    Improvement in VAS - Worst leg of 20mm at 24 months compared to baseline

  2. VAS - Back [ Time Frame: 24 months ]
    Improvement in VAS - Back pain of 20mm at 24 months compared to baseline

  3. ODI [ Time Frame: 24 months ]
    Improvement in ODI of 15 points at 24 months compared to baseline

  4. ODI [ Time Frame: 24 months ]
    Mean change in ODI over time intervals

  5. VAS [ Time Frame: 24 months ]
    Mean change in leg VAS over time intervals

  6. VAS [ Time Frame: 24 months ]
    Mean change in back VAS over time intervals

  7. Radiographically confirmed subsidence [ Time Frame: 24 months ]
    Absence of radiographically confirmed subsidence >5mm


Other Outcome Measures:
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 24 months ]
    Improvement in PROMIS scores at 24 months relative to the baseline.

  2. Demographics [ Time Frame: 24 months ]
    The study will examine the patient population through descriptive statistics of the demographic variable - age

  3. Demographics [ Time Frame: 24 months ]
    The study will examine the patient population through descriptive statistics of the demographic variable - Body Mass Index (BMI)

  4. Demographics [ Time Frame: 24 months ]
    The study will examine the patient population through descriptive statistics of the demographic variable - gender

  5. Intra-Operative Variables [ Time Frame: 24 months ]
    The study will examine the patient population through descriptive statistics of the intra-operative variable - surgery time.

  6. Intra-Operative Variables [ Time Frame: 24 months ]
    The study will examine the patient population through descriptive statistics of the intra-operative variable - blood loss

  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05438719


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

Locations
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United States, Colorado
Steamboat Orthopaedic & Spine Institute (SOSI) Recruiting
Steamboat Springs, Colorado, United States, 80487
Contact: Abigail Wiedel       mailto:awiedel@steamboatortho.com   
Principal Investigator: Alex Sielatycki, MD         
United States, North Carolina
Pinehurst Surgical Clinic Recruiting
Pinehurst, North Carolina, United States, 29374
Contact: Courtney Elliott       celliott@pinehurstsurgical.com   
Principal Investigator: Alexander Lemons, MD         
Sub-Investigator: Daniel Williams, MD         
United States, Tennessee
Center for Sports Medicine and Orthopaedics Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Danette Newton    423-634-2696    danettenewton@gmail.com   
Principal Investigator: Benjamin Geddes, MD         
Sponsors and Collaborators
3Spine
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Responsible Party: 3Spine
ClinicalTrials.gov Identifier: NCT05438719    
Other Study ID Numbers: BalancedBack IDE
First Posted: June 30, 2022    Key Record Dates
Last Update Posted: February 6, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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