Boston Sports & Shoulder Center, 840 Winter Street, Waltham, MA, 02451, USA.
New England Baptist Hospital, Boston, MA, 02120, USA.
BMC Musculoskelet Disord. 2024 Nov 30;25(1):984. doi: 10.1186/s12891-024-08110-9.
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.
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.
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.
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.
足部和踝关节融合术通常与骨移植物的使用同时进行。然而，自体骨的可用性常常受到限制，难以获得或不适用，因此需要具有同等临床效果的骨移植物替代物。已经开发出了一种下一代整合骨基质（IBM），它具有内在的成骨、骨传导和诱导成骨特性，是一种有前途的解决方案，可以减轻诸如骨不连等并发症，并减少对自体骨移植物采集的需求。
回顾性分析了 20 例接受 INFLUX™ SPARC 新型 IBM 足部和踝关节融合术的患者的病历，以确定这种下一代骨移植物的初步临床安全性和疗效。终点包括并发症或手术再次干预的发生、通过标准影像学片确定的融合率以及在 24 周内的不同时间点的患者报告的结果测量。
本研究中未观察到重大并发症或手术再次干预。所有患者在 24 周时均达到完全影像学融合，总体融合时间平均为 8.5±4.8 周。在整个随访期间，主观疼痛、功能和生活质量结果均持续改善，所有患者（100%）在 24 周时均达到所有测量指标的最小临床显著改善平均值。
这项研究支持将这种新型 IBM 用作自体骨移植的有前途的替代物，它具有较高的融合成功率、较低的并发症发生率和临床上有意义的患者报告结果改善，特别是在高风险患者群体中。需要进一步的研究来在更大和更长的研究中证实这些发现，并探索这种创新骨移植物的更广泛应用。
