BMAC & Allograft vs BMP-2

Prospective, Blinded, Non-randomized Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate and Allograft Versus Recombinant Bone Morphogenetic Protein-2 (BMP)

The aim of this investigation is to compare the use of bone marrow aspirate concentrate (BMAC) and allograft versus recombinant human bone morphogenetic protein-2 (BMP) versus the gold standard fusion in subjects undergoing elective lumbar spinal fusion with interbody support. The safety and efficacy of the surgical interventions will be evaluated by assessing fusion status and subjects' quality of life outcomes.

This study will be a prospective, randomized clinical study at a single-center, NYU Langone Medical Center. It is intended to compare and evaluate the efficacy of subjects who are either treated with (1) bone marrow aspirate concentrate (BMAC) and allograft or (2) recombinant human bone morphogenetic protein-2 (BMP) or (3) autograft (control) during lumbar spinal fusion with interbody support. The clinical, radiographic, and Health Related Quality of Life (HRQOL) outcomes will be assessed in operatively treated adult spinal degenerative disease patients undergoing lumbar spinal fusion.

Inclusion Criteria:

• Must be 18 years old or older
• Scheduled for elective posterior or anterior and posterior spinal fusion of the thoracolumbar spine with or without anterior interbody support
• Failed at least 6 weeks of conservative care
• No contraindication to BMAC (as per manufacturer)
• Signed consent form

Exclusion criteria:

• Prior lumbar fusion surgery at operative level (prior discectomy and/or laminectomy allowed)
• Incompetent or missing anterior arch at the affected level (e.g. laminectomy, pars defect)
• Currently requires laminectomy at level of surgery
• Facet joints at implant level are absent or fractured
• Post-traumatic vertebral body compromise or acute fracture at implant level
• Body mass Index (BMI) > 40
• Known allergy to titanium
• Paget's disease, osteomalacia, or any other metabolic bone disease
• Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids)
• Unlikely to comply with the follow-up evaluation schedule
• Active malignancy defined as history of invasive malignancy, except if the subject has received treatment and displayed no clinical signs and symptoms for at least five years
• Pregnant or planning to become pregnant during the length of study participation