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ORIGINAL RESEARCH article

Front. Musculoskelet. Disord.
Sec. Systemic Inflammatory Joint Diseases
Volume 2 - 2024 | doi: 10.3389/fmscd.2024.1459266
This article is part of the Research Topic Frontiers in Regenerative Medicine: Applications Across Musculoskeletal Health View all articles

An Innovative Advance in Bone Grafting: Initial Clinical Results Using a Novel Integrative Bone Graft in Spinal Fusion

Provisionally accepted
Peter Passias Peter Passias *Oluwatobi O Onafowokan Oluwatobi O Onafowokan Ankita Das Ankita Das Jamshaid M Mir Jamshaid M Mir Anthony Yung Anthony Yung Max Fisher Max Fisher
  • Duke University Health System, Durham, United States

The final, formatted version of the article will be published soon.

    Introduction Although autologous iliac crest bone graft (ICBG) has long been the gold standard for spinal fusion, complications related to its harvest and availability issues with local bone autograft have encouraged the development of bone graft substitutes that provide safer alternatives with consistent clinical efficacy and potential for applications across musculoskeletal health, including spinal fusion. This study evaluates the initial safety and efficacy of a novel integrative bone matrix (IBM) in spinal fusion procedures. Methods The charts of twenty patients who underwent spinal fusion surgery at 1 – 5 contiguous interbody levels and/or 1 – 15 contiguous posterolateral levels with the novel IBM between November 2022 and May 2023 were retrospectively evaluated for safety and efficacy endpoints at standard of care 3, 6, and 12 months postoperative follow up visits. Radiographic fusion rate was evaluated by plain radiographs using the Bridwell interbody fusion grading system and/or the Glassman posterolateral fusion grading system, as appropriate. Subjective pain, disability, and quality of life assessments included the EuroQoL 5 Dimensions Visual Analogue Scale (EQ-5D VAS), Oswestry Disability Index (ODI), and the revised Scoliosis Research Society Score (SRS-22r). Results No adverse events occurred that were related to the graft, and no subjects required unplanned revision surgery. Radiographic fusion was achieved in all (100%) of the interbody and posterolateral levels by 12 months. There was no significant difference in overall fusion rate between subjects receiving short versus long segment constructs. At 3, 6, and 12 month follow up, significant (p<0.001) improvements were observed compared to baseline values for all patient reported outcome measures, and the cohort reached the minimum clinically significant mean improvements. Discussion This study highlights the potential of this novel IBM as a safe and effective bone graft substitute in spinal arthrodesis procedures. Patients had a high rate of fusion without any graft-related adverse events. Larger, controlled studies with longer-term follow-up are warranted for further validation.

    Keywords: Spinal Fusion, Bone graft, Spine surgery, biologics, Regenerative Medicine, integrative bone matrix, IBM

    Received: 03 Jul 2024; Accepted: 17 Dec 2024.

    Copyright: © 2024 Passias, Onafowokan, Das, Mir, Yung and Fisher. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Peter Passias, Duke University Health System, Durham, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.