Back to resultsProspective Study of Thoracolumbar Spinal Fusion Graft (BMAC)
Primary Purpose
Lumbar Degenerative Disc Disease
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BMAC & Allograft
Iliac Crest Bone Graft
Sponsored by
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
Arm Type
Active Comparator
Active Comparator
Arm Label
BMAC & Allograft
Iliac Crest Bone Graft
Arm Description
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.
Outcomes
Primary Outcome Measures
CT scan to assess fusion status
Oswestry Disability Index (ODI)
Short Form Health Survey (SF-12)
Numeric Pain Rating Scale
Length of Stay
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02297256
Brief Title
Prospective Study of Thoracolumbar Spinal Fusion Graft
Acronym
BMAC
Official Title
Prospective Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate Versus Iliac Crest Bone Graft
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2012 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Degenerative Disc Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMAC & Allograft
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Iliac Crest Bone Graft
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
BMAC & Allograft
Other Intervention Name(s)
Bone Marrow Aspirate Concentrate & Allograft
Intervention Description
Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion.
Intervention Type
Procedure
Intervention Name(s)
Iliac Crest Bone Graft
Other Intervention Name(s)
ICBG
Intervention Description
Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.
Primary Outcome Measure Information:
Title
CT scan to assess fusion status
Time Frame
Pre-operative, Post Operative 1 Year
Title
Oswestry Disability Index (ODI)
Time Frame
Pre-operative, Post Operative 1 Year
Title
Short Form Health Survey (SF-12)
Time Frame
Pre-op, Post Operative 1 Year
Title
Numeric Pain Rating Scale
Time Frame
Pre-op, Post Operative 1 Year
Title
Length of Stay
Time Frame
Post Operative 1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Passias, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Hospital for Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Center for Musculoskeletal Care (CMC)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NY Spine Institute
City
Westbury
State/Province
New York
ZIP/Postal Code
11590
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10436164
Citation
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.
Results Reference
background
PubMed Identifier
18639333
Citation
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.
Results Reference
background
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Prospective Study of Thoracolumbar Spinal Fusion Graft
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