Prospective Study of Thoracolumbar Spinal Fusion Graft

Completed · Not applicable

Conditions studied: Lumbar Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT02297256

Run by

NYU Langone Health

People needed

17

Starts

2012-08-24

Expected to finish

2020-11-24

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be 18 years old or older
• Scheduled for elective posterior spinal fusion of the thoracolumbar spine or lumbar spine with or without anterior interbody support
• Failed at least 6 weeks of conservative care
• ODI v2.1 score > 30%
• No contraindication to BMAC (as per manufacturer)
• Signed consent form

You may not qualify if…

• Spondylolisthesis grade ≥ 3
• Pagets disease, osteomalacia, or any metabolic bone disease
• Use of medications that interfere with bone healing (chronic steroids)
• Patient unlikely to comply with post-op schedule with physician
• Recent history of chemical dependency
• Participation in other investigational device trial(s) within past 30 days
• Active malignancy
• Pregnancy or planning to become pregnant
• Direct involvement in execution of this protocol

Where it is running

• NYU Hospital for Joint Diseases — New York, New York, United States
• Center for Musculoskeletal Care (CMC) — New York, New York, United States
• NY Spine Institute — Westbury, New York, United States

Full record on ClinicalTrials.gov

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