Spinal Fusion Graft Techniques for Degenerative Disc Disease

(BMAC Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Chronic steroids

Disqualifiers: Spondylolisthesis, Metabolic bone disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Surgery and immediate recovery

17 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial excludes people using medications that interfere with bone healing, like chronic steroids, so you may need to stop those. The protocol doesn't specify about other medications.

What data supports the effectiveness of the treatment BMAC & Allograft, Iliac Crest Bone Graft for spinal fusion in degenerative disc disease?

Research shows that using concentrated bone marrow aspirate (BMA) with allograft can be an effective alternative to iliac crest bone graft for spinal fusion, as BMA contains cells and growth factors that help bone healing. However, the effectiveness may vary in elderly patients due to a natural decline in these cells with age. ^{1 2 3 4 5}

Is spinal fusion using BMAC and iliac crest bone graft safe?

Studies show that using bone marrow aspirate concentrate (BMAC) from the iliac crest can cause pain and complications at the harvest site, but it is generally considered safe. Alternatives like cell-based grafts and allografts are being explored to reduce these issues. ^{2 3 6 7 8}

How is the treatment BMAC & Allograft, Iliac Crest Bone Graft for degenerative disc disease different from other treatments?

This treatment is unique because it combines concentrated bone marrow aspirate (BMAC), which contains stem cells and growth factors, with allograft bone, offering both osteogenic (bone-forming) and osteoinductive (bone growth-stimulating) properties. This approach may provide an alternative to traditional iliac crest bone grafts, which can cause donor site pain, and is particularly relevant for elderly patients who may have a reduced stem cell population. ^{1 2 3 4 9}

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.

Research Team

Peter Passias, MD

Principal Investigator

NYU School of Medicine

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

My back pain affects my daily life significantly.

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

No contraindication to BMAC (as per manufacturer)

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo posterior lumbar/lumbosacral spinal fusion with either BMAC + allograft or ICBG

Surgery and immediate recovery

Follow-up

Participants are monitored for fusion rate and health-related quality of life parameters

2 years

Visits at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively

Treatment Details

Interventions

• BMAC & Allograft
• Iliac Crest Bone Graft

Trial Overview 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.

Participant Groups

Group I: BMAC & Allograft Active Control 1 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 Graft Active Control 1 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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistant matrix versus iliac crest bone graft. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Clinical and radiographic outcomes of concentrated bone marrow aspirate with allograft and demineralized bone matrix for posterolateral and interbody lumbar fusion in elderly patients. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Use of biphasic calcium phosphate versus demineralized bone matrix: retrospective clinical and CT analysis of posterolateral fusion results. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A comparison of mesenchymal precursor cells and amnion epithelial cells for enhancing cervical interbody fusion in an ovine model. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Comparing the efficacy of syngeneic iliac and femoral allografts with iliac crest autograft in a rat model of lumbar spinal fusion. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Pain and Complications Following Bone Marrow Aspirate Concentrate Harvested From the Iliac Crest in Foot and Ankle Surgery. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Iliac crest bone graft versus cell-based grafts to augment spinal fusion: a systematic review and meta-analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Bone marrow aspirate concentrate with cancellous allograft versus iliac crest bone graft in the treatment of long bone nonunions. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Anterior cervical discectomy and fusion with "mini-invasive" harvesting of iliac crest graft versus polyetheretherketone (PEEK) cages: a retrospective outcome analysis. [2021]