Prospective Randomized Three Arm Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone marrow aspirate concentrate & Allograft versus Recombinant Bone Morphogenetic Protein-2 (BMP) versus Control Group

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Spinal Disease
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Scheduled for elective posterior or anterior and posterior spinal fusion of the thoracolumbar spine with or without anterior interbody support.
    2. Failed at least 6 weeks of conservative care
    3. Oswestry Disability Index (ODI) score > 30%
    4. No contraindication to BMAC (as per manufacturer)

You may not be eligible for this study if the following are true:

    1. Prior lumbar fusion surgery at operative level (prior discectomy and/or laminectomy allowed)
    2. Spondylolisthesis grade 3 or more
    3. Incompetent or missing anterior arch at the affected level (e.g. laminectomy, pars defect)
    4. Currently requires laminectomy at level of surgery
    5. Facet joints at implant level are absent or fractured
    6. Post-traumatic vertebral body compromise or acute fracture at implant level
    7. Body mass Index (BMI) > 40
    8. Known allergy to titanium
    9. Paget’s disease, osteomalacia, or any other metabolic bone disease
    10. Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids)
    11. Dentato Rubro Thalamic Tract (drtt)
    12. Subject has recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation
    13. Participation in a clinical trial of another investigational drug or device within the past 30 days
    14. Systemic infection such as AIDS, HIV, and active hepatitis
    15. Active malignancy defined as history of invasive malignancy
    16. Pregnant or planning to become pregnant during the length of study participation
    17. Involvement in active litigation related to back problems at the time of screening (this does not apply to litigation required by no fault states)
    18. Direct involvement in the execution of this protocol
    19. Intraoperative exclusion: Any change in the surgical procedure PRIOR to surgery that violates the inclusion/exclusion criteria.

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