Prospective Study of Thoracolumbar Spinal Fusion Graft

NCT02297256 | Completed Results DMC

• 1 other identifier: 12-02411
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

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.

Conditions

Lumbar Degenerative Disc Disease

Outcome Measures

Primary Outcomes (5)

• Spinal Fusion Grade at 1 Year Via CT Scan

  Spinal fusion grade refers to the assessment of how well vertebrae fuse together after surgery, often evaluated using imaging like CT scans or radiographs. Grades typically range from complete fusion (Grade I) to non-union or pseudarthrosis (Grade IV), indicating varying degrees of bone healing and stability.

  Post Operative 1 Year

• Change in Oswestry Disability Index (ODI) Score

  The Oswestry Disability Index (ODI) score ranges from 0 to 100, with higher scores indicating greater disability. A score of 0% represents no disability, while a score of 100% represents complete disability. The ODI is often interpreted using categories: 0-20% (minimal disability), 21-40% (moderate disability), 41-60% (severe disability), 61-80% (crippling), and 81-100% (bedridden or functional impairment).

  Pre-operative, Post Operative 1 Year

• Short Form Health Survey (SF-12)

  The SF-12 is a shorter version of the SF-36, designed to assess health-related quality of life. Scores range from 0 to 100. Scores above 50 indicate better-than-average health-related quality of life for that component. Scores below 50 indicate below-average health-related quality of life.

  Pre-op, Post Operative 1 Year

• Change in Numeric Pain Rating Scale Score From Baseline (Pre-op) and 1 Year Post Operative

  The numeric pain rating scale (NRS) is a tool used to assess pain intensity, commonly using a scale of 0 to 10, where 0 indicates "no pain" and 10 represents the "worst pain imaginable"

  Pre-op, Post Operative 1 Year

• Length of Stay in Hospital, Measured in Days

  Post Operative 1 Year

Study Arms (2)

BMAC & Allograft

ACTIVE COMPARATOR

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

Iliac Crest Bone Graft

ACTIVE COMPARATOR

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

Interventions

BMAC & Allograft PROCEDURE

Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion.

Also known as: Bone Marrow Aspirate Concentrate & Allograft

BMAC & Allograft

Iliac Crest Bone Graft PROCEDURE

Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.

Also known as: ICBG

Iliac Crest Bone Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (3)

NYU Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Center for Musculoskeletal Care (CMC)

New York, New York, 10016, United States

Location

NY Spine Institute

Westbury, New York, 11590, United States

Location

Related Publications (2)

• 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.

  PMID: 10436164 BACKGROUND

• 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.

  PMID: 18639333 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Transplantation, Homologous

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Peter Passias
• Organization: NYU Langone Health

peter.passias@nyumc.org

516-387-8777

Study Officials

• Peter Passias, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: November 21, 2014
• Study Start: August 24, 2012
• Primary Completion: November 1, 2018
• Study Completion: November 24, 2020
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-04

Locations

US (3)