Initial clinical evaluation of a novel integrative bone matrix (IBM) in foot and ankle fusion procedures.

Autor: Hofmann KJ; Boston Sports & Shoulder Center, 840 Winter Street, Waltham, MA, 02451, USA. khofmann@bostonssc.com.; New England Baptist Hospital, Boston, MA, 02120, USA. khofmann@bostonssc.com., Veale NJ; Boston Sports & Shoulder Center, 840 Winter Street, Waltham, MA, 02451, USA., Veale M; Boston Sports & Shoulder Center, 840 Winter Street, Waltham, MA, 02451, USA., Glass E; Boston Sports & Shoulder Center, 840 Winter Street, Waltham, MA, 02451, USA., Beckles M; Boston Sports & Shoulder Center, 840 Winter Street, Waltham, MA, 02451, USA.
Jazyk: angličtina
Zdroj: BMC musculoskeletal disorders [BMC Musculoskelet Disord] 2024 Nov 30; Vol. 25 (1), pp. 984. Date of Electronic Publication: 2024 Nov 30.
DOI: 10.1186/s12891-024-08110-9
Abstrakt: Background: Foot and ankle arthrodesis procedures are frequently performed in concert with the utilization of bone grafts. However, the availability of autologous bone is often limited, inaccessible, or not suitable, thus there is a need for bone graft substitutes with equally effective clinical outcomes. A next generation integrative bone matrix (IBM) has been developed that has intrinsic osteogenic, osteoconductive, and osteoinductive characteristics, and is a promising solution to mitigate complications such as nonunion and reduce the need for autologous bone graft harvest.
Methods: The charts of twenty subjects undergoing foot and ankle fusion procedures with INFLUX™ SPARC, a novel IBM, were retrospectively reviewed to determine initial clinical safety and efficacy of this next generation bone graft. Endpoints included the presence of complications or surgical reintervention, fusion rates as determined by standardized radiographic films, and patient-reported outcome measures at various time points up to 24 weeks.
Results: No major complications or surgical reinterventions were observed in this study. Complete radiographic fusion was achieved in all subjects by 24 weeks, with a mean overall fusion time of 8.5 ± 4.8 weeks. Subjective pain, function, and quality of life outcomes showed consistent improvements throughout the follow-up period, and all subjects (100%) achieved the minimum clinically significant mean improvements for all measures by week 24.
Conclusions: This study supports the use of this new IBM as a promising alternative to autologous bone grafting, offering high fusion success rates, low complications, and clinically meaningful improvements in patient-reported outcomes, particularly in higher-risk patient populations. Future investigations are needed to confirm these findings in larger and longer-term studies, and to explore the broader applications of this innovative bone graft.
Competing Interests: Declarations. Ethics approval and consent to participate: A Waiver of Informed Consent and HIPAA was granted by New England Baptist Hospital IRB after review of the study protocol, due to its retrospective nature (approval #1876063). This work was conducted in accordance with the ethical principles in the Declaration of Helsinki and conducted according to U.S. and international standards of Good Clinical Practice in accordance with applicable Federal regulations, International Council for Harmonization guidelines, and institutional research policies and procedures. Consent for publication: Not applicable. Competing interests: K.J.H. reports that they are a consultant for ISTO Biologics. The other authors report no competing interests.
(© 2024. The Author(s).)
Databáze: MEDLINE
Externí odkaz: