Prospective Study of Thoracolumbar Spinal Fusion Graft (BMAC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02297256|
Recruitment Status : Active, not recruiting
First Posted : November 21, 2014
Last Update Posted : June 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Degenerative Disc Disease||Procedure: BMAC & Allograft Procedure: Iliac Crest Bone Graft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospective Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate Versus Iliac Crest Bone Graft|
|Actual Study Start Date :||August 2012|
|Actual Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2021|
Active Comparator: 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.
Procedure: 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.
Other Name: Bone Marrow Aspirate Concentrate & Allograft
Active Comparator: 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.
Procedure: Iliac Crest Bone Graft
Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.
Other Name: ICBG
- CT scan to assess fusion status [ Time Frame: Pre-operative, Post Operative 1 Year ]
- Oswestry Disability Index (ODI) [ Time Frame: Pre-operative, Post Operative 1 Year ]
- Short Form Health Survey (SF-12) [ Time Frame: Pre-op, Post Operative 1 Year ]
- Numeric Pain Rating Scale [ Time Frame: Pre-op, Post Operative 1 Year ]
- Length of Stay [ Time Frame: Post Operative 1 Year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297256
|United States, New York|
|NYU Hospital for Joint Diseases|
|New York, New York, United States, 10003|
|Center for Musculoskeletal Care (CMC)|
|New York, New York, United States, 10016|
|NY Spine Institute|
|Westbury, New York, United States, 11590|
|Principal Investigator:||Peter Passias, MD||NYU School of Medicine|