Prospective Study of Thoracolumbar Spinal Fusion Graft (BMAC)

Prospective Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate Versus Iliac Crest Bone Graft

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lumbar Degenerative Disc Disease
• Intervention / Treatment: Procedure: BMAC & Allograft; Procedure: Iliac Crest Bone Graft

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • NYU Hospital for Joint Diseases
    • New York, New York, United States, 10016
      • Center for Musculoskeletal Care (CMC)
    • Westbury, New York, United States, 11590
      • NY Spine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: ICBG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CT scan to assess fusion status	Pre-operative, Post Operative 1 Year
Oswestry Disability Index (ODI)	Pre-operative, Post Operative 1 Year
Short Form Health Survey (SF-12)	Pre-op, Post Operative 1 Year
Numeric Pain Rating Scale	Pre-op, Post Operative 1 Year
Length of Stay	Post Operative 1 Year

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Peter Passias, MD, NYU School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): November 1, 2018
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimated): November 21, 2014

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: 12-02411

Drug and device information, study documents

• 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