Prospective Study of Thoracolumbar Spinal Fusion Graft

Study Overview
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Brief Summary
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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.

Detailed Description
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Subjects who are candidates for posterior lumbar or lumbosacral spinal fusion without anterior interbody support will be screened for inclusion in the study. Participants will be enrolled and randomized to either the BMAC + allograft or ICBG group. An enrollment ratio of two BMAC + allograft to one ICBG subject (2:1) for up to a total of 40 subjects will be enrolled in the study which also accounts for failed screening subjects. The study will determine and compare differences in fusion rate and health related quality of life parameters at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively.

Official Title
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Prospective Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate Versus Iliac Crest Bone Graft

Conditions
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Lumbar Degenerative Disc Disease

Intervention / Treatment
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* Procedure: BMAC & Allograft
* Procedure: Iliac Crest Bone Graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMAC & Allograft<br>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. | Procedure: BMAC & Allograft<br>* Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion.<br>* Other names: Bone Marrow Aspirate Concentrate & Allograft;|
| Active Comparator: Iliac Crest Bone Graft<br>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. | Procedure: Iliac Crest Bone Graft<br>* Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.<br>* Other names: ICBG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT scan to assess fusion status |  | Pre-operative, Post Operative 1 Year | 
| Oswestry Disability Index (ODI) |  | Pre-operative, Post Operative 1 Year | 
| Short Form Health Survey (SF-12) |  | Pre-op, Post Operative 1 Year | 
| Numeric Pain Rating Scale |  | Pre-op, Post Operative 1 Year | 
| Length of Stay |  | Post Operative 1 Year |