NCT02297256

Prospective Study of Thoracolumbar Spinal Fusion Graft

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lumbar Degenerative Disc Disease

Interventions

Type	Name	Description
PROCEDURE	BMAC & Allograft	Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion.
PROCEDURE	Iliac Crest Bone Graft	Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.

Timeline

• Start date: 2012-08-01
• Primary completion: 2018-11-01
• Completion: 2025-12-01
• First posted: 2014-11-21
• Last updated: 2024-09-03

Locations

3 sites across 1 country: United States