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

Brief description of study

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.

Clinical Study Identifier: s16-01160

ClinicalTrials.gov Identifier: NCT02924571

Principal Investigator: Themistocles Protopsaltis.

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