Top

Published in:

Open Access 01-12-2024 | Research

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

Authors: Kurt J. Hofmann, Nicholas J. Veale, Matt Veale, Evan Glass, Matthew Beckles

Published in: BMC Musculoskeletal Disorders | Issue 1/2024

Abstract

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.

Leslie MD, Schindler C, Rooke GMJ, Dodd A. CT-Verified Union Rate following arthrodesis of ankle, Hindfoot, or midfoot: a systematic review. Foot Ankle Int. 2023;44(7):665. https://doi.org/10.1177/10711007231171087.CrossRefPubMedPubMedCentral

Frey C, Halikus NM, vu-Rose T, Ebramzadeh E. A review of ankle arthrodesis: predisposing factors to nonunion. Foot Ankle Int. 1994;15(11):581–4. https://doi.org/10.1177/107110079401501102.CrossRefPubMed

Gazdag AR, Lane JM, Glaser D, Forster RA. Alternatives to Autogenous Bone Graft: efficacy and indications. J Am Acad Orthop Surg. 1995;3(1):1–8. https://doi.org/10.5435/00124635-199501000-00001.CrossRefPubMed

Kim DH, Rhim R, Li L, et al. Prospective study of iliac crest bone graft harvest site pain and morbidity. Spine J. 2009;9(11):886–92. https://doi.org/10.1016/J.SPINEE.2009.05.006.CrossRefPubMed

van de Wall BJM, Beeres FJP, Rompen IF, et al. RIA versus iliac crest bone graft harvesting: a meta-analysis and systematic review. Injury. 2022;53(2):286–93. https://doi.org/10.1016/J.INJURY.2021.10.002.CrossRefPubMed

Bae HW, Zhao L, Kanim LEA, Wong P, Delamarter RB, Dawson EG. Intervariability and intravariability of bone morphogenetic proteins in commercially available demineralized bone matrix products. Spine (Phila Pa 1976). 2006;31(12):1299–306. https://doi.org/10.1097/01.BRS.0000218581.92992.B7.CrossRefPubMed

Li J, Zhang YP, Kirsner RS. Angiogenesis in wound repair: angiogenic growth factors and the extracellular matrix. Microsc Res Tech. 2003;60(1):107–14. https://doi.org/10.1002/JEMT.10249.CrossRefPubMed

Glazebrook M, Beasley W, Daniels T, et al. Establishing the relationship between clinical outcome and extent of osseous bridging between computed tomography assessment in isolated hindfoot and ankle fusions. Foot Ankle Int. 2013;34(12):1612–8. https://doi.org/10.1177/1071100713504746.CrossRefPubMed

Daniels TR, Anderson J, Swords MP, et al. Recombinant human platelet-derived growth factor BB in Combination with a Beta-tricalcium phosphate (rhPDGF-BB/β-TCP)-Collagen matrix as an alternative to Autograft. Foot Ankle Int. 2019;40(9):1068–78. https://doi.org/10.1177/1071100719851468.CrossRefPubMed

10.

Budiman-Mak E, Conrad KJ, Roach KE. The foot function index: a measure of foot pain and disability. J Clin Epidemiol. 1991;44(6):561–70. https://doi.org/10.1016/0895-4356(91)90220-4.CrossRefPubMed

11.

Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994;15(7):349–53. https://doi.org/10.1177/107110079401500701.CrossRefPubMed

12.

Ware JE, Kosinski M, Keller SD. A 12-Item short-form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–33. https://doi.org/10.1097/00005650-199603000-00003.CrossRefPubMed

13.

Daabiss M. American Society of Anaesthesiologists physical status classification. Indian J Anaesth. 2011;55(2):111–5. https://doi.org/10.4103/0019-5049.79879.CrossRefPubMedPubMedCentral

14.

Daniels TR, Younger ASE, Penner MJ, et al. Prospective randomized controlled trial of Hindfoot and ankle fusions treated with rhPDGF-BB in Combination with a β-TCP-Collagen matrix. Foot Ankle Int. 2015;36(7):739–48. https://doi.org/10.1177/1071100715576370.CrossRefPubMed

15.

Albrektsson T, Johansson C. Osteoinduction, osteoconduction and osseointegration. Eur Spine J. 2001;10(Suppl 2):S96. https://doi.org/10.1007/S005860100282.CrossRefPubMedPubMedCentral

16.

Collman DR, Kaas MH, Schuberth JM. Arthroscopic ankle arthrodesis: factors influencing union in 39 consecutive patients. Foot Ankle Int. 2006;27(12):1079–85. https://doi.org/10.1177/107110070602701214.CrossRefPubMed

17.

Thordarson DB, Kuehn S. Use of demineralized bone matrix in ankle/hindfoot fusion. Foot Ankle Int. 2003;24(7):557–60. https://doi.org/10.1177/107110070302400706.CrossRefPubMed

18.

Schlickewei C, Neumann JA, Yarar-Schlickewei S, et al. Does demineralized bone Matrix affect the Nonunion rate in arthroscopic ankle arthrodesis? J Clin Med. 2022;11(13). https://doi.org/10.3390/JCM11133893.

19.

DeVries JG, Scharer B. Comparison and use of allograft bone morphogenetic protein Versus other materials in ankle and hindfoot fusions. J Foot Ankle Surg. 2018;57(4):707–11. https://doi.org/10.1053/J.JFAS.2017.12.010.CrossRefPubMed

20.

Müller MA, Frank A, Briel M, et al. Substitutes of structural and non-structural autologous bone grafts in hindfoot arthrodeses and osteotomies: a systematic review. BMC Musculoskelet Disord. 2013;14. https://doi.org/10.1186/1471-2474-14-59.

21.

Lareau CR, Deren ME, Fantry A, Donahue RMJ, DiGiovanni CW. Does autogenous bone graft work? A logistic regression analysis of data from 159 papers in the foot and ankle literature. Foot Ankle Surg. 2015;21(3):150–9. https://doi.org/10.1016/J.FAS.2015.03.008.CrossRefPubMed

22.

Moran TE, Sequeira S, Cooper MT, Park J. A retrospective analysis of outcomes from foot and ankle arthrodesis and open reduction and internal fixation using Cellular Bone Allograft Augmentation. Foot Ankle Spec. 2022;15(4):312–20. https://doi.org/10.1177/1938640020952301.CrossRefPubMed

23.

Roukis TS, Wetzell B, McLean JB, Dorsch K, Moore MA. A retrospective comparison of clinical and patient-reported outcomes in Foot and Ankle Arthrodesis procedures using two Cellular Bone allografts. Clin Res Foot Ankle. 2020;8(4):1–6.

24.

Hollawell SM. Allograft cellular bone matrix as an alternative to autograft in hindfoot and ankle fusion procedures. J Foot Ankle Surg. 2012;51(2):222–5. https://doi.org/10.1053/J.JFAS.2011.10.001.CrossRefPubMed

25.

Scott RT, Hyer CF. Role of cellular allograft containing mesenchymal stem cells in high-risk foot and ankle reconstructions. J Foot Ankle Surg. 2013;52(1):32–5. https://doi.org/10.1053/J.JFAS.2012.09.004.CrossRefPubMed

26.

Rush SM, Hamilton GA, Ackerson LM. Mesenchymal stem cell allograft in revision foot and ankle surgery: a clinical and radiographic analysis. J Foot Ankle Surg. 2009;48(2):163–9. https://doi.org/10.1053/J.JFAS.2008.12.008.CrossRefPubMed

27.

Jones CP, Loveland J, Atkinson BL, Ryaby JT, Linovitz RJ, Nunley JA, Prospective. Multicenter evaluation of allogeneic bone Matrix containing viable osteogenic cells in Foot and/or ankle arthrodesis. Foot Ankle Int. 2015;36(10):1129–37. https://doi.org/10.1177/1071100715586181.CrossRefPubMed

28.

Loveland JD, Waldorff EI, He DY, Atkinson BL. A retrospective clinical comparison of two allogeneic bone matrices containing viable osteogenic cells in patients undergoing foot and/or ankle arthrodesis. J Stem Cell Res Ther. 2017;7(10):1–7. https://doi.org/10.4172/2157-7633.1000405.CrossRef

29.

Skovrlj B, Guzman JZ, Al Maaieh M, Cho SK, Iatridis JC, Qureshi SA. Cellular bone matrices: viable stem cell-containing bone graft substitutes. Spine J. 2014;14(11):2763–72. https://doi.org/10.1016/J.SPINEE.2014.05.024.CrossRefPubMedPubMedCentral

30.

Martin GJ, Boden SD, Titus L, Scarborough NL. New formulations of demineralized bone matrix as a more effective graft alternative in experimental posterolateral lumbar spine arthrodesis. Spine (Phila Pa 1976). 1999;24(7):637–45. https://doi.org/10.1097/00007632-199904010-00005.CrossRefPubMed

Title: Initial clinical evaluation of a novel integrative bone matrix (IBM) in foot and ankle fusion procedures
Authors: Kurt J. Hofmann
Nicholas J. Veale
Matt Veale
Evan Glass
Matthew Beckles
Publication date: 01-12-2024
Publisher: BioMed Central
Published in: BMC Musculoskeletal Disorders / Issue 1/2024
Electronic ISSN: 1471-2474
DOI: https://doi.org/10.1186/s12891-024-08110-9

In non-elite athletes, women are more likely to return to sports after anterior cruciate ligament reconstruction: a retrospective cohort study

Open Access
Research

Comparison of early clinical outcome in carpal tunnel release - mini-open technique with palmar incision vs. endoscopic technique with wrist crease incision-

Open Access
Incision
Research

Straight intramedullary MultiLoc nails for displaced proximal humeral fractures: health status, radiographic results, clinical outcome, and complications

Open Access
Research

Identification of key genes and long non‑coding RNA expression profiles in osteoporosis with rheumatoid arthritis based on bioinformatics analysis

Open Access
Osteoporosis
Research

Comparison of short-term clinical outcomes between open-wedge high tibial osteotomy and tibial condylar valgus osteotomy

Open Access
Osteoarthrosis
Research

Transcriptome sequencing and bioinformatics analysis of gastrocnemius muscle in type 2 diabetes mellitus rats

Open Access
Sarcopenia
Research

Keynote series | Spotlight on menopause

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusions

Other articles of this Issue 1/2024

In non-elite athletes, women are more likely to return to sports after anterior cruciate ligament reconstruction: a retrospective cohort study

Comparison of early clinical outcome in carpal tunnel release - mini-open technique with palmar incision vs. endoscopic technique with wrist crease incision-

Straight intramedullary MultiLoc nails for displaced proximal humeral fractures: health status, radiographic results, clinical outcome, and complications

Identification of key genes and long non‑coding RNA expression profiles in osteoporosis with rheumatoid arthritis based on bioinformatics analysis

Comparison of short-term clinical outcomes between open-wedge high tibial osteotomy and tibial condylar valgus osteotomy

Transcriptome sequencing and bioinformatics analysis of gastrocnemius muscle in type 2 diabetes mellitus rats

Keynote series | Spotlight on menopause

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Please log in to get access to this content

In non-elite athletes, women are more likely to return to sports after anterior cruciate ligament reconstruction: a retrospective cohort study

Comparison of early clinical outcome in carpal tunnel release - mini-open technique with palmar incision vs. endoscopic technique with wrist crease incision-

Straight intramedullary MultiLoc nails for displaced proximal humeral fractures: health status, radiographic results, clinical outcome, and complications

Identification of key genes and long non‑coding RNA expression profiles in osteoporosis with rheumatoid arthritis based on bioinformatics analysis

Comparison of short-term clinical outcomes between open-wedge high tibial osteotomy and tibial condylar valgus osteotomy

Transcriptome sequencing and bioinformatics analysis of gastrocnemius muscle in type 2 diabetes mellitus rats