Russell Nicholas, Walsh William R, Lovric Vedran, Kim Peter, Chen Jennifer H, Larson Michael J, Vizesi Frank
SeaSpine Inc., Carlsbad, CA, United States.
Surgical and Orthopaedic Research Laboratories, Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia.
Front Surg. 2020 Mar 20;7:10. doi: 10.3389/fsurg.2020.00010. eCollection 2020.
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. 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. The study objectives were to evaluate the 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. The DBF/DBM products evaluated were: Strand 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. 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. 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 performance. In the absence of definitive clinical evidence, surgeons should carefully consider available data in valid animal models when selecting demineralized allograft options.
脱矿骨基质（DBM）是脊柱融合术中广泛使用的骨移植材料。大多数市售的DBM由悬浮在载体中的脱矿骨颗粒（约125 - 800微米）组成，载体改善了其操作性，但稀释了骨诱导成分。DBM纤维（DBF）具有更好的骨传导性，且不需要载体。有人提出，100%的DBF可能比含载体的颗粒状DBM性能更好。在无胸腺大鼠后外侧融合模型中对七种市售的DBM产品进行了测试。其中有四种100%的DBF、两种含载体的DBF和一种含载体的颗粒状DBM。研究目的是评估其性能：（1）比较六种市售DBF和一种颗粒状DBM的融合率和融合成熟度，（2）评估载体对后外侧融合模型中DBF融合结果的影响。所评估的DBF/DBM产品包括：Strand Family、Propel® DBM纤维、Vesuvius®脱矿纤维、Optium® DBM油灰、Grafton® DBF、Grafton Flex和DBX®油灰。对69只无胸腺大鼠进行了单节段后外侧融合手术。4周后通过手动触诊、X线片和CT检查双侧是否有桥接骨来评估融合情况。用CT成熟度分级量表和组织学方法评估融合块的成熟度。使用Fisher精确检验对分类数据进行统计分析，使用Kruskal - Wallis检验对非参数数据进行统计分析。通过手动触诊、X线片和CT评估，Strand Family实现了100%的融合（18/18），显著高于Propel纤维、Vesuvius纤维、Optium油灰和DBX油灰，在统计学上不高于Grafton DBF和Grafton Flex。Strand Family的融合成熟度最高，CT成熟度等级为2.3/3.0，成熟融合率为89%。融合结果表明载体对融合性能有不利影响。在一个成熟的临床前融合模型中，七种市售DBM产品的融合性能存在很大差异。不同的100% DBF产品之间甚至存在显著差异，这表明仅成分并不能保证性能。在缺乏确凿临床证据的情况下，外科医生在选择脱矿同种异体移植选项时应仔细考虑有效动物模型中的现有数据。
