Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

BMAC & Allograft vs BMP-2

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02924571
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The aim of this investigation is to compare the use of bone marrow aspirate concentrate (BMAC) and allograft versus to recombinant human bone morphogenetic protein-2 (BMP) in subjects undergoing elective thoracolumbar spinal fusion with interbody support. The investigators will look at the safety and efficacy of these two different surgical methods by assessing surgery outcomes and participants' quality of life.

Condition or disease Intervention/treatment Phase
Spinal Fusion Procedure: Bone Marrow Aspirate Concentrate (BMAC) Procedure: Recombinant Human Bone Morphogenetic Protein-2 (BMP) Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be 18 years old or older
  • Scheduled for elective posterior or anterior and posterior spinal fusion of the thoracolumbar spine with or without anterior interbody support
  • Failed at least 6 weeks of conservative care
  • No contraindication to BMAC (as per manufacturer)
  • Signed consent form

Exclusion criteria:

  • Prior lumbar fusion surgery at operative level (prior discectomy and/or laminectomy allowed)
  • Incompetent or missing anterior arch at the affected level (e.g. laminectomy, pars defect)
  • Currently requires laminectomy at level of surgery
  • Facet joints at implant level are absent or fractured
  • Post-traumatic vertebral body compromise or acute fracture at implant level
  • Body mass Index (BMI) > 40
  • Known allergy to titanium
  • Paget's disease, osteomalacia, or any other metabolic bone disease
  • Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids)
  • Unlikely to comply with the follow-up evaluation schedule
  • Active malignancy defined as history of invasive malignancy, except if the subject has received treatment and displayed no clinical signs and symptoms for at least five years
  • Pregnant or planning to become pregnant during the length of study participation

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Peter Passias 212-231-5470 peter.passias@nyumc.org
Contact: Gregory Poorman gwpoorman@gmail.com

Locations
Layout table for location information
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         
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Peter Passias NYU Langone Medical Center

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02924571     History of Changes
Other Study ID Numbers: 16-01160
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

Layout table for additional information
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