In-vivo Performance of Seven Commercially Available Demineralized Bone Matrix Fiber and Putty Products in a Rat Posterolateral Fusion Model

Abstract

Introduction: Demineralized bone matrix (DBM) is a widely used bone graft in spinal fusion. Most commercial DBMs are composed of demineralized bone particles (∼125-800 microns) suspended in a carrier that provides improved handling but dilutes the osteoinductive component. DBM fibers (DBF) provide improved osteoconductivity and do not require a carrier. It has been suggested that 100% DBF may offer improved performance over particulate-based DBMs with carrier.Study Design: Seven commercially available DBM products were tested in an athymic rat posterolateral fusion model. There were four 100% DBFs, two DBFs containing a carrier, and one particulate-based DBM containing carrier.Objective: The study objectives were to evaluate the in vivo performance: (1) compare fusion rate and fusion maturity of six commercially available DBFs and one particulate-based DBM, and (2) assess the effect of carrier on fusion outcomes for DBFs in a posterolateral fusion model. Methods:The DBF/DBM products evaluated were: Strand TM Family, Propel ® DBM Fibers, Vesuvius ® Demineralized Fibers, Optium ® DBM Putty, Grafton ® DBF, Grafton Flex, and DBX ® Putty. Single-level posterolateral fusion was performed in 69 athymic rats. Fusion was assessed bilaterally after 4 weeks by manual palpation, radiograph and CT for bridging bone. Fusion mass maturity was assessed with a CT maturity grading scale and by histology. Statistical analysis was performed using Fishers Exact Test for categorical data and Kruskal-Wallis Test for non-parametric data.Results: Strand Family achieved 100% fusion (18/18) by manual palpation, radiographic and CT evaluation, significantly higher than Propel Fibers, Vesuvius Fibers, Optium Putty, and DBX Putty, and not statistically higher than Grafton DBF and Grafton Flex. Strand Family provided the highest fusion maturity, with CT maturity grade of 2.3/3.0 and 89% mature fusion rate. Fusion results suggest a detrimental effect of carrier on fusion performance. Russell et al. Performance of Demineralized Bone FibersConclusions: There were large variations in fusion performance for seven commercially available DBM products in an established preclinical fusion model. There were even significant differences between different 100% DBF products, suggesting that composition alone does not guarantee in vivo performance. In the absence of definitive clinical evidence, surgeons should carefully consider available data in valid animal models when selecting demineralized allograft options.

Caprine demineralized bone matrix (DBMc) in the repair of non-critical bone defects in rabbit tibias. A new bone xenograft

“…In this study, microtomographic images gave detailed information on the progression of bone repair over time in both groups, as reported in other studies 28 . The rate of tissue repair increased at the experimental times (15,30,60 and 90 days). The macroscopically structure and regeneration was similar in both groups, but the healing rate was faster in control group.…”

“…Statistical analysis was performed by applying parametric tests. To compare the results obtained in the control group (CG), the matrix group (MG) and the different euthanasia times (15,30, 60 and 90 days), the ANOVA analysis of variance test was used. The means between control group and matrix at each euthanasia time were then compared using the T student test, considering a significance level of 95% (p <0.05).…”

“…However, it has been known that autologous grafting has limitation related to donor site morbidity and volume of possible harvesting, leading to an imminent necessity of searching for a suitable and widely available bone graft 13 . Among numerous options of bone substitutes, demineralized bone matrix (DBM) has been considered versatile and extensively used for repairing bone, in humans and veterinary patients 14,15 .…”

“…The MG (matrix group) was represented by the left tibia of each rabbit (n=24) and received the implant of DBMc, while the CG (control group) was compounded by the right tibia (n=24), in which no biomaterial was used. Later, they were separated into 4 groups with 6 animals (n=12), according to the period of analysis (15,30,60 and 90 days postoperatively). individually identified, according to time of collection and whether or not DBMc had been used.…”

Understanding the Future Prospects of Synergizing Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgery with Ceramics and Regenerative Cellular Therapies

“…The varying BMP concentration in commercial DBM greatly impacts its clinical efficacy [ 37 ]. In an athymic rat model, a large variation in fusion performance of DBM and demineralized bone fiber (DBF) of seven commercial products (StrandTM Family, Propel ® DBM Fibers, Vesuvius ® Demineralized Fibers, Optium ® DBM Putty, Grafton ® DBF, Grafton Flex, and DBX ® Putty) was observed, and outcomes indicated a detrimental influence of the carrier on the fusion performance; hence, DBM allografts should be carefully selected [ 112 ]. Research has also shown that different commercial DBM products (Grafton Putty, DBX Putty, and AlloMatrix Injectable Putty) may results in varying magnitude of new bone formation and radiographically evident spinal fusion [ 113 ].…”