Introduction. Autogenous bone graft is the gold standard in reconstruction of bone defects. The use of autogenous bone graft is problematic because of limited bone as well as donor site morbidity. This study evaluates a novel biomaterial as an alternative to autogenous bone graft. The biomaterial is amniotic membrane, rich in growth factors. Methods. Twenty-one adult male Sprague-Dawley rats were implanted with biomaterial using the rat critical size femoral gap model. After creation of the critical size femoral gap animals were randomized to one of the following groups: Group 1 (control): gap left empty and received no treatment; Group 2 (experimental): the gap was filled with commercially available bone graft; Group 3 (experimental): the gap was filled with bone graft plus NuCel amniotic tissue preparation. Results. The experimental groups demonstrated new bone formation compared to controls. The results were evident on radiographs and histology. Histology showed Group 1 controls to have 11.1% new bone formation, 37.8% for Group 2, and 49.2% for Group 3. These results were statistically significant. Conclusions. The study demonstrates that amniotic membrane products have potential to provide bridging of bone defects. Filling bone defects without harvesting autogenous bone would provide a significant improvement in patient care. 1. Introduction Although autologous iliac crest bone graft (AICBG) remains the “gold standard” in the reconstruction of bone defects, there are disadvantages, including a limited amount of bone and donor site morbidity [1]. Many bone graft substitutes have therefore been developed, including silicone, polymethylmethacrylate (PMMA) [2], porous polyethylene [3], hydroxyapatite, demineralized bone matrix (DBM), and tricalcium phosphate [4]. As foreign bodies, however, these alloplastic materials have their own inherent disadvantages, including increased infection and extrusion rates. Recent developments in the treatment of bone defects include the reamer irrigator aspirator system (RIA), Masquelet technique (induced membrane), bone marrow aspirate concentrate (BMAC), and BMP-2 combined with cancellous allograft [1]. Although novel, these new techniques lack high-level evidence for their widespread adoption. Tissue engineering has provided an attractive alternative to the use of synthetic implants and growth factors by using biodegradable materials of natural origin to form tissue constructs. The advantage to the tissue engineered approach to bone repair as reported in this study is the use of materials that are rapidly degrading
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