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Bone Graft

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

N/A

Waitlist Available

Led By Peter Passias, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Pagets disease, osteomalacia, or any metabolic bone disease

Use of medications that interfere with bone healing (chronic steroids)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two methods of spinal fusion surgery to see which is more effective. One group will receive bone marrow aspirate concentrate (BMAC), and the other will receive allograft to iliac crest bone grafts (ICBG).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include pain at the graft site, infection risk, bleeding complications, nerve damage risks associated with spinal surgery, and possible failure to achieve desired pain relief or structural support.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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My back pain affects my daily life significantly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I currently have cancer.

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My spine condition is severe, with one vertebra significantly slipping over another.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 7Eligibility criteria met