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

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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

Brief description of study

The purpose of this study is to determine if a spinal fusion technique using Bone Marrow Aspirate Concentrate (BMAC), bone marrow obtained from the hip bone and then concentrated in a machine, plus an allograft (bone graft from a donor) is as safe and works as well as the more commonly used spinal fusion technique using bone morphogenic protein (a protein in the body that promoted bone growth) compared to an autograft (bone marrow obtained from the same person). Participation in this study will involve 7 visits, which will take place over a 2 year period from the time of screening to study completion.

Clinical Study Identifier: s16-01160

ClinicalTrials.gov Identifier: NCT02924571

Principal Investigator: Peter G. Passias.

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