BMAC & Allograft vs BMP-2
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|ClinicalTrials.gov Identifier: NCT02924571|
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : January 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Fusion||Procedure: Bone Marrow Aspirate Concentrate (BMAC) Procedure: Recombinant Human Bone Morphogenetic Protein-2 (BMP)||Not Applicable|
Currently, there are many available orthopaedic graft adjuncts which each have their own advantages and disadvantages. For example, although effective, BMPs are very expensive and have a risk of side effects. The use of BMAC may be a good alternative to the use of BMPs, and may not have the same side effects.
Subjects who are scheduled for an elective spinal fusion and are enrolled in the study will be assigned to receive either BMP or BMAC. Subjects will be asked to complete questionnaires relating to quality of life, use of pain killers, and overall health, as well as have standard radiographic studies to examine the spine pre- and post-surgically. Subjects will attend 7 visits, which happen at the same time as the standard of care visits they would normally attend for their condition. Subjects will be followed in the study for 2 years in total.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Prospective, Blinded, Non-randomized Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate and Allograft Versus Recombinant Bone Morphogenetic Protein-2 (BMP)|
|Actual Study Start Date :||July 24, 2018|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
|Experimental: Bone Marrow Aspirate Concentrate (BMAC)||
Procedure: Bone Marrow Aspirate Concentrate (BMAC)
Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest (BMAC+ ALLOGRAFT) or
|Active Comparator: Recombinant Human Bone Morphogenetic Protein-2 (BMP)||
Procedure: Recombinant Human Bone Morphogenetic Protein-2 (BMP)
INFUSE rhBMP-2 Bone Graft (BMP). Using the standard technique for anterior lateral fusion, the bone graft from group 1 or 2 will be laid onto the decorticated transverse processes, lateral aspects of the facets, par interarticularis, and onto the facets.
Other Name: rhBMP-2
- Oswestry Disability Index (ODI) [ Time Frame: Baseline to 2 Years ]Differences from pre-operative visit to post-operative time points will be compared between BMAC and BMP groups by Student t-tests.
- SF-12 (Short Form Health Survey) [ Time Frame: Baseline to 2 Years ]Differences from pre-operative visit to post-operative time points will be compared between BMAC and BMP groups by Student t-tests.
- Numeric Pain Rating Scale (NRS) [ Time Frame: Baseline to 2 Years ]Differences from pre-operative visit to post-operative time points will be compared between BMAC and BMP groups by Student t-tests.
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): NCT02924571
|Contact: Peter Passiasfirstname.lastname@example.org|
|Contact: Gregory Poormanemail@example.com|
|United States, New York|
|New York University School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Mohamed Moawad 212-231-5470 Mohamed.Moawad@nyumc.org|
|Principal Investigator: Peter Passias, MD|
|Principal Investigator:||Peter Passias||NYU Langone Medical Center|