Prospective Study of Thoracolumbar Spinal Fusion Graft (BMAC)
Lumbar Degenerative Disc Disease
About this trial
This is an interventional prevention trial for Lumbar Degenerative Disc Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- NYU Hospital for Joint Diseases
- Center for Musculoskeletal Care (CMC)
- NY Spine Institute
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
BMAC & Allograft
Iliac Crest Bone Graft
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.
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.