BalancedBack Total Joint Replacement Investigational Device Exemption Study

• ClinicalTrials.gov Identifier: NCT05438719
• Recruitment Status: Recruiting
• First Posted: June 30, 2022
• Last Update Posted: May 1, 2023
• Sponsor: 3Spine
• Information provided by (Responsible Party): 3Spine

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

United States, California

Todd H. Lanman, MD Inc.; Recruiting

Los Angeles, California, United States, 90210

Contact: Nicole Phillips

Contact research@spine.md

Principal Investigator: Todd Lanman, MD

Sub-Investigator: Jason Cueller, MD

Sub-Investigator: Jared Ament, MD

United States, Colorado

Steamboat Orthopaedic & Spine Institute (SOSI); Active, not recruiting

Steamboat Springs, Colorado, United States, 80487

United States, New York

Upstate Ortho; Recruiting

East Syracuse, New York, United States, 13057

Contact: Tina Craig craigt@upstate.edu

Principal Investigator: William Lavelle, MD

Sub-Investigator: Richard Tallarico, MD

Sub-Investigator: Mike Sun, MD

United States, North Carolina

Pinehurst Surgical Clinic; Recruiting

Pinehurst, North Carolina, United States, 29374

Contact: Mia Ferry mferry@pinehurstsurgical.com

Principal Investigator: Alexander Lemons, MD

Sub-Investigator: Daniel Williams, MD

United States, Tennessee

Center for Sports Medicine and Orthopaedics; Active, not recruiting

Chattanooga, Tennessee, United States, 37404

United States, Texas

Orthopedic San Antonio; Recruiting

San Antonio, Texas, United States, 78229

Contact: Brouk Gebreab brouk.gebreab@christushealth.org

Principal Investigator: Anton Jorgensen, MD

United States, Utah

The Disc Replacement Center; Recruiting

West Jordan, Utah, United States, 84088

Contact: Aubrianna Cicon aubrianna.cicon@steward.org

Principal Investigator: Armen Khachatryan, MD

Sponsors and Collaborators

3Spine

More Information

• Responsible Party: 3Spine
• ClinicalTrials.gov Identifier: NCT05438719
• Other Study ID Numbers: BalancedBack IDE
• First Posted: June 30, 2022
• Last Update Posted: May 1, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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