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Completed

NCT Number: NCT02297256

Prospective Study of Thoracolumbar Spinal Fusion 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.

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Key information

Conditions

Lumbar Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Musculoskeletal Care (CMC), New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Bone Marrow Aspirate Concentrate & Allograft

Iliac Crest Bone Graft

Procedure

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

Other names: ICBG

Primary outcomes

  1. Spinal Fusion Grade at 1 Year Via CT Scan

    Time frame: Post Operative 1 Year

    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.

  2. Change in Oswestry Disability Index (ODI) Score

    Time frame: Pre-operative, Post Operative 1 Year

    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).

  3. Short Form Health Survey (SF-12)

    Time frame: Pre-op, Post Operative 1 Year

    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.

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

    Time frame: Pre-op, Post Operative 1 Year

    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"

  5. Length of Stay in Hospital, Measured in Days

    Time frame: Post Operative 1 Year

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Acronym: BMAC

Important dates

Study start
2012
Primary completion
2018
Study completion
2020
First posted
Nov 21, 2014
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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