SLR - September 2022 - Amanda Chao, DPM PGY-3
Reference: Downing, Michael & Niedzielak, Timothy & Rosa, Charles & Ting, Alexander & Berko, Joshua & Lampasona, Nicholas & Cross, Brian. (2021). A literature review of commercially available demineralized bone matrix products and their clinical evidence in acute fractures, nonunions, and fusion procedures. Current Orthopaedic Practice. 2021 January. 32(2):197-203.Level Of Evidence: III
Scientific Literature Review
Reviewed by: Amanda Chao, DPM PGY-3
Residency Program: Legacy Health - Portland OR
Podiatric Relevance: Demineralized bone matrix (DBM) is a widely used adjunct when autograft is not readily available to the surgeon. Its osteoconductive and osteoinductive properties provide support for osseous defects secondary to infection, trauma, reconstruction, and fusion. There is little published literature demonstrating the differing efficacy and outcomes of DBM products. This literature review is one of the few studies out there that has directly compared DBM products in the setting of clinical outcomes, safety, and efficacy.
Methods: The study is a literature review that has analyzed the outcomes of DBM products for fractures, non-unions, and fusions of the upper and lower extremity. The products critically analyzed with clinical evidence in an orthopaedic setting from these articles included Allomatrix, DBX, Grafton, Orthoblast, and Osteosponge. These products were evaluated of its specific FDA improved indication, published contraindications, and clinical outcomes demonstrated in the individual study. Product cost and form of product was also reviewed.
Results: Twelve articles were reviewed after extensive inclusion and exclusion criteria. Allomatrix demonstrated no significant difference in healing rates of distal radius and femoral fractures and long bone nonunions when compared to the use of autograft. A retrospective, comparative study of 75 patients who were either treated with autograft or Grafton for tibial nonunions, demonstrated 97 percent of the patients who were treated with Grafton, went on to healing with a mean healing time of 4.2 months. A comparative study of 28 patients with metaphyseal and periarticular defects of the upper and lower extremities and acetabular fractures either treated with Orthoblast and Grafton showed greater outcomes of healing in the Orthoblast group overall. Brigido et. al evaluated the use of Osteosponge in arthrodesis of the foot and ankle. 80 total joints were treated with Osteosponge, including the ankle joint, syndesmosis, subtalar joint, talonavicular, calcaneocuboid, naviculocuneiform, lesser tarsometatarsal, and metatarsophalangeal joints. 78/80 (97.5 percent) union was demonstrated with improved pain and function at the 12-month follow-up post-operatively. Allomatrix and DBX were the most cost-effective products per cost unit, $455.38/3cc and $768.67/5cc, respectively. Grafton had the most number of readily available forms out of all the products.
Conclusions: All twelve articles reviewed proved good clinical outcomes of the individual DBM products with at least a year of follow-up postoperatively and no statistically significant difference with overall healing when compared to different DBM prodcuts and autograft in the setting of fractures, nonunions, and fusions. This literature review is one the few publications that has analyzed demineralized bone matrix products and their application and results. This signifies how little of higher level of evidence is published in regard to DBM products’ clinical outcomes, efficacy, and indication. Grafton and Allomatrix were the two most clinically researched DBM products with clinical studies and published data. Allomatrix and DBM are the most cost-effective products available. When using DBM, it is imperative that there is a healthy, vascular tissue bed without significant patient comorbidities and critical decision making to ensure appropriate indication and form of product used.