Spinal Fusion Graft Techniques for Degenerative Disc Disease
(BMAC Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byPeter Passias, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 who need elective posterior spinal fusion for thoracolumbar or lumbar spine issues and have not improved after 6 weeks of non-surgical care. They must be able to follow post-op plans, not be pregnant, nor involved in other device trials recently, and free from certain bone diseases or chemical dependencies.

Inclusion Criteria

I am 18 years old or older.

My back pain affects my daily life significantly.

I am scheduled for a specific back surgery involving the middle to lower spine.

+3 more

Exclusion Criteria

I have a bone condition like Paget's disease or osteomalacia.

I am not taking medications like chronic steroids that affect bone healing.

I currently have cancer.

+6 more

Participant Groups

The study compares the effectiveness of two types of spinal fusion grafts: one using a combination of bone marrow aspirate concentrate (BMAC) with allograft versus the traditional iliac crest bone graft (ICBG). It's a randomized clinical trial at a single center.

2Treatment groups

Active Control

Group I: BMAC & AllograftActive Control1 Intervention

Subjects will be treated with bone marrow aspirate concentrate (BMAC) and allograft during posterior lumbar/lumbosacral spinal fusion. During lumbar spine surgery, 12 teaspoons of bone marrow will be taken (aspirated) from one side of hip bone. This may be repeated on the other side of hip bone for a total of 12, 24, or 36 teaspoons of bone marrow total taken from your hip bone depending on the decision made by the surgeon. The bone marrow will then be concentrated with a machine for 15 minutes to a final volume of 2, 4, or 6 teaspoons of BMAC. BMAC will be combined with packed allograft bone chips using another machine to produce two or three constructed bone logs. The bone logs will be laid along the backside of the spine and between each vertebral body.

Group II: Iliac Crest Bone GraftActive Control1 Intervention

Subjects who are in the Iliac Crest Bone Graft arm will be treated with Iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion. During lumbar spine surgery, the surgeon will make an incision to expose the iliac crest (hip bone), and cutting out the segments of the bone that will be needed, based on the decision of the surgeon. The bone chips will be laid along the backside of the spine and also between each vertebral body where the bone will fuse into place. When the bone becomes solid/fused, there is no movement in the fused spine.