Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Lumbar Degenerative Disc Disease Procedure: BMAC & Allograft Procedure: Iliac Crest Bone Graft Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. CT scan to assess fusion status [ Time Frame: Pre-operative, Post Operative 1 Year ]
  2. Oswestry Disability Index (ODI) [ Time Frame: Pre-operative, Post Operative 1 Year ]
  3. Short Form Health Survey (SF-12) [ Time Frame: Pre-op, Post Operative 1 Year ]
  4. Numeric Pain Rating Scale [ Time Frame: Pre-op, Post Operative 1 Year ]
  5. Length of Stay [ Time Frame: Post Operative 1 Year ]


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 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

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): NCT02297256


Locations
Layout table for location information
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
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Peter Passias, MD NYU School of Medicine
Publications:
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02297256    
Other Study ID Numbers: 12-02411
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021

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
Additional relevant MeSH terms:
Layout table for MeSH terms
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases