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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMAC & Allograft | Active Comparator | 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. |
|
| Iliac Crest Bone Graft | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMAC & Allograft | Procedure | Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal Fusion Grade at 1 Year Via CT Scan | Spinal fusion grade refers to the assessment of how well vertebrae fuse together after surgery, often evaluated using imaging like CT scans or radiographs. Grades typically range from complete fusion (Grade I) to non-union or pseudarthrosis (Grade IV), indicating varying degrees of bone healing and stability. | Post Operative 1 Year |
| Change in Oswestry Disability Index (ODI) Score | The Oswestry Disability Index (ODI) score ranges from 0 to 100, with higher scores indicating greater disability. A score of 0% represents no disability, while a score of 100% represents complete disability. The ODI is often interpreted using categories: 0-20% (minimal disability), 21-40% (moderate disability), 41-60% (severe disability), 61-80% (crippling), and 81-100% (bedridden or functional impairment). | Pre-operative, Post Operative 1 Year |
| Short Form Health Survey (SF-12) | The SF-12 is a shorter version of the SF-36, designed to assess health-related quality of life. Scores range from 0 to 100. Scores above 50 indicate better-than-average health-related quality of life for that component. Scores below 50 indicate below-average health-related quality of life. | Pre-op, Post Operative 1 Year |
| Change in Numeric Pain Rating Scale Score From Baseline (Pre-op) and 1 Year Post Operative | The numeric pain rating scale (NRS) is a tool used to assess pain intensity, commonly using a scale of 0 to 10, where 0 indicates "no pain" and 10 represents the "worst pain imaginable" | Pre-op, Post Operative 1 Year |
| Length of Stay in Hospital, Measured in Days | Post Operative 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Passias, MD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Hospital for Joint Diseases | New York | New York | 10003 | United States | ||
| Center for Musculoskeletal Care (CMC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10436164 | Background | Asahara T, Masuda H, Takahashi T, Kalka C, Pastore C, Silver M, Kearne M, Magner M, Isner JM. Bone marrow origin of endothelial progenitor cells responsible for postnatal vasculogenesis in physiological and pathological neovascularization. Circ Res. 1999 Aug 6;85(3):221-8. doi: 10.1161/01.res.85.3.221. | |
| 18639333 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | BMAC & Allograft | 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. BMAC & Allograft: Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion. |
| FG001 | Iliac Crest Bone Graft | 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. Iliac Crest Bone Graft: Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BMAC & Allograft | 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. BMAC & Allograft: Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spinal Fusion Grade at 1 Year Via CT Scan | Spinal fusion grade refers to the assessment of how well vertebrae fuse together after surgery, often evaluated using imaging like CT scans or radiographs. Grades typically range from complete fusion (Grade I) to non-union or pseudarthrosis (Grade IV), indicating varying degrees of bone healing and stability. | Posted | Mean | Standard Deviation | score on a scale | Post Operative 1 Year |
|
2 year post-operatively
Occurrence of adverse events was assessed at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively during standard office visits. Additional adverse events reported asynchronously by patients were captured on an as-needed basis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMAC & Allograft | 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. BMAC & Allograft: Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reoperation - mechanical failure/hardware failure/non-union | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Passias | NYU Langone Health | 516-387-8777 | peter.passias@nyumc.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 11, 2013 | Mar 19, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014184 | Transplantation, Homologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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|
| Iliac Crest Bone Graft | Procedure | Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion. |
|
|
| New York |
| New York |
| 10016 |
| United States |
| NY Spine Institute | Westbury | New York | 11590 | United States |
| Gan Y, Dai K, Zhang P, Tang T, Zhu Z, Lu J. The clinical use of enriched bone marrow stem cells combined with porous beta-tricalcium phosphate in posterior spinal fusion. Biomaterials. 2008 Oct;29(29):3973-82. doi: 10.1016/j.biomaterials.2008.06.026. Epub 2008 Jul 18. |
| BG001 | Iliac Crest Bone Graft | 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. Iliac Crest Bone Graft: Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Iliac Crest Bone Graft | 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. Iliac Crest Bone Graft: Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion. |
|
|
| Primary | Change in Oswestry Disability Index (ODI) Score | The Oswestry Disability Index (ODI) score ranges from 0 to 100, with higher scores indicating greater disability. A score of 0% represents no disability, while a score of 100% represents complete disability. The ODI is often interpreted using categories: 0-20% (minimal disability), 21-40% (moderate disability), 41-60% (severe disability), 61-80% (crippling), and 81-100% (bedridden or functional impairment). | Posted | Mean | 95% Confidence Interval | percent change | Pre-operative, Post Operative 1 Year |
|
|
|
| Primary | Short Form Health Survey (SF-12) | The SF-12 is a shorter version of the SF-36, designed to assess health-related quality of life. Scores range from 0 to 100. Scores above 50 indicate better-than-average health-related quality of life for that component. Scores below 50 indicate below-average health-related quality of life. | Posted | Mean | Standard Deviation | score on a scale | Pre-op, Post Operative 1 Year |
|
|
|
| Primary | Change in Numeric Pain Rating Scale Score From Baseline (Pre-op) and 1 Year Post Operative | The numeric pain rating scale (NRS) is a tool used to assess pain intensity, commonly using a scale of 0 to 10, where 0 indicates "no pain" and 10 represents the "worst pain imaginable" | Posted | Mean | Standard Deviation | score on a scale | Pre-op, Post Operative 1 Year |
|
|
|
| Primary | Length of Stay in Hospital, Measured in Days | Posted | Mean | Standard Deviation | Days | Post Operative 1 Year |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Iliac Crest Bone Graft | 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. Iliac Crest Bone Graft: Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion. | 0 | 5 | 0 | 5 | 2 | 5 |
| Reoperation - infection | Surgical and medical procedures | Systematic Assessment |
|
| Reoperation - Persistent radiculopathy | Surgical and medical procedures | Systematic Assessment |
|
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