Trial Outcomes & Findings for Prospective Study of Thoracolumbar Spinal Fusion Graft (NCT NCT02297256)
NCT ID: NCT02297256
Last Updated: 2026-04-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Post Operative 1 Year
Results posted on
2026-04-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
5
|
|
Overall Study
COMPLETED
|
12
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BMAC & Allograft
n=12 Participants
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.
|
Iliac Crest Bone Graft
n=5 Participants
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.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.33 years
STANDARD_DEVIATION 15.35 • n=12 Participants
|
53 years
STANDARD_DEVIATION 15.68 • n=5 Participants
|
53.94 years
STANDARD_DEVIATION 14.96 • n=17 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=12 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=12 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=17 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
5 participants
n=5 Participants
|
17 participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Post Operative 1 YearSpinal 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.
Outcome measures
| Measure |
BMAC & Allograft
n=12 Participants
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.
|
Iliac Crest Bone Graft
n=5 Participants
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.
|
|---|---|---|
|
Spinal Fusion Grade at 1 Year Via CT Scan
|
1.67 score on a scale
Standard Deviation 0.98
|
2.4 score on a scale
Standard Deviation 1.52
|
PRIMARY outcome
Timeframe: Pre-operative, Post Operative 1 YearThe 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).
Outcome measures
| Measure |
BMAC & Allograft
n=12 Participants
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.
|
Iliac Crest Bone Graft
n=5 Participants
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.
|
|---|---|---|
|
Change in Oswestry Disability Index (ODI) Score
|
-24 percent change
Interval -37.6 to -11.3
|
-43 percent change
Interval -67.8 to -18.2
|
PRIMARY outcome
Timeframe: Pre-op, Post Operative 1 YearThe 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.
Outcome measures
| Measure |
BMAC & Allograft
n=12 Participants
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.
|
Iliac Crest Bone Graft
n=5 Participants
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.
|
|---|---|---|
|
Short Form Health Survey (SF-12)
|
5.11 score on a scale
Standard Deviation 6.92
|
3.87 score on a scale
Standard Deviation 5.86
|
PRIMARY outcome
Timeframe: Pre-op, Post Operative 1 YearThe 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"
Outcome measures
| Measure |
BMAC & Allograft
n=12 Participants
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.
|
Iliac Crest Bone Graft
n=5 Participants
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.
|
|---|---|---|
|
Change in Numeric Pain Rating Scale Score From Baseline (Pre-op) and 1 Year Post Operative
|
-2.58 score on a scale
Standard Deviation 1.88
|
-1.8 score on a scale
Standard Deviation 3.11
|
PRIMARY outcome
Timeframe: Post Operative 1 YearOutcome measures
| Measure |
BMAC & Allograft
n=12 Participants
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.
|
Iliac Crest Bone Graft
n=5 Participants
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.
|
|---|---|---|
|
Length of Stay in Hospital, Measured in Days
|
5.08 Days
Standard Deviation 1.62
|
5.4 Days
Standard Deviation 1.52
|
Adverse Events
BMAC & Allograft
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Iliac Crest Bone Graft
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BMAC & Allograft
n=12 participants at risk
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.
|
Iliac Crest Bone Graft
n=5 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Reoperation - Persistent radiculopathy
|
8.3%
1/12 • 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.
|
0.00%
0/5 • 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.
|
|
Surgical and medical procedures
Reoperation - mechanical failure/hardware failure/non-union
|
16.7%
2/12 • 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.
|
40.0%
2/5 • 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.
|
|
Surgical and medical procedures
Reoperation - infection
|
8.3%
1/12 • 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.
|
0.00%
0/5 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place