BMAC & Allograft vs BMP-2

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Spinal Fusion

Clinical Trial Details

NCT number	NCT02924571
Study type	Interventional
Source	NYU Langone Health
Contact
Status	Active, not recruiting
Phase	N/A
Start date	July 24, 2018
Completion date	January 2025

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