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Prospective Study of Thoracolumbar Spinal Fusion Graft — BMAC  

Lumbar Degenerative Disc Disease Clinical Trial

Official title:
Prospective Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate Versus Iliac Crest Bone Graft

Clinical Trial Summary

This study is a single-center, prospective randomized clinical study intended to compare and evaluate the efficacy of subjects who are treated with bone marrow aspirate concentrate (BMAC) and allograft to iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.

Clinical Trial Description

Subjects who are candidates for posterior lumbar or lumbosacral spinal fusion without anterior interbody support will be screened for inclusion in the study. Participants will be enrolled and randomized to either the BMAC + allograft or ICBG group. An enrollment ratio of two BMAC + allograft to one ICBG subject (2:1) for up to a total of 40 subjects will be enrolled in the study which also accounts for failed screening subjects. The study will determine and compare differences in fusion rate and health related quality of life parameters at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02297256
Study type Interventional
Source NYU Langone Health
Contact
Status Active, not recruiting
Phase N/A
Start date August 2012
Completion date December 1, 2025
View Details
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