Background: Insufficient data exist on bone graft substitute materials efficacy; two thirds lack any clinical data. 1,2 This prospective animal study identified efficacy differences among commercially available materials of several classes. Methods: Historically validated muscle pouch osteoinduction study (OIS) and posterolateral fusion (PLF) were performed in an athymic rat model. Grafting material products implanted were demineralized bone matrix (DBM)based allografts (Accell EVO3, DBX Mix, DBX Strip, Grafton Crunch, Grafton Flex, Grafton Matrix, Grafton Putty, Magnifuse, and Progenix Plus), allografts (OsteoSponge, MinerOss), cellular allograft (Osteocel Plus), ceramics (Mozaik Strip), or activated ceramics (Actifuse ABX Putty, Vitoss BA). After 4 weeks, OIS specimens were evaluated ex vivo by histologic osteoinductivity. After 8 weeks, PLF ex vivo specimens were evaluated for fusion by manual palpation (F MP), radiography (F XR), and histology (F HISTO). Results: OIS: No materials exhibited a rejection reaction on histology. All DBM-based materials exhibited osteoinductive potential as new bone formation at. 88% of implanted sites. One plain allograft (OsteoSponge) formed bone at 25% of sites. No bone formed for one ceramic (Mozaik Strip), three activated ceramics (Actifuse ABX Putty), or one cellular allograft, regardless of human bone marrow aspirate (hBMA) when added. PLF: Among the 10 DBMs, 6 had F MP of 100% (Accell EVO3, DBX Mix, DBX Strip, Grafton Flex, Grafton Putty, Magnifuse), 2 had F MP of 94% (Grafton Crunch, Grafton Matrix), and 2 conditions had F MP of 0% (Progenix Plus, Progenix Plus þ athymic rat iliac crest bone graft [arICBG]). Ceramics (Mozaik Strip), activated ceramics (Actifuse ABX Putty, Vitoss BA), plain allograft (OsteoSponge, MinerOss (PLF study), and cellular allograft (Osteocel Plus) demonstrated 0% F MP. ArICBG demonstrated 13% F MP. Conclusions: Eight DBM-based materials (Accell EVO3, DBX Mix, DBX Strip, Grafton Crunch, Grafton Flex, Grafton Matrix, Grafton Putty, Magnifuse) demonstrated excellent (. 90% F MP) efficacy in promoting fusion via bone healing. Two DBM conditions (Progenix Plus, Progenix Plus þ arICBG) showed no manual palpation fusion (F MP). Systematically, over the 2 studies (OIS and PLF), cellular (Osteocel Plus), plain allografts (OsteoSponge, MinerOss; PLF study), ceramic (Mozaik Strip), and activated ceramics (Actifuse ABX Putty, Vitoss BA) demonstrated poor F MP efficacy (, 10%). Clinical Relevance: When selecting DBMs, clinicians must be cognizant of variability in DBM efficacy by product and lot. While theoretically osteoinductive, cellular allograft and activated ceramics yielded poor in vivo efficacy. Whole allograft and ceramics may provide osteoconductive scaffolding for mixed-material grafting; however, surgeons should be cautious in using them alone. Direct clinical data are needed to establish efficacy for any bone graft substitute.
Vitamin D plays a significant role in musculoskeletal health by regulating calcium, phosphate, and promoting new bone mineralization. The purpose of this study was to understand the effect of dietary vitamin D on general bone health during peri-operative bone healing via an in vivo dosing study of vitamin D in a rat posterolateral fusion model using autograft. Vitamin D Deficient (DD), vitamin D Insufficient (ID), Control vitamin D (CD), and Hyper-vitamin D (HD) groups were studied. Increasing dietary vitamin D improved quantitative measures of femoral geometry, including femoral strength, stiffness, and density. Femoral biomechanics, cortical thickness, moment of inertia, cross-sectional area, and measures from bone ashing were all greater in the HD group versus the CD. This suggests that additional dietary vitamin D above normal levels during spinal fusion may lead to improvement in bone health. Serum vitamin D levels were also observed to decrease during fusion healing. These results demonstrate that dietary vitamin D improves general bone health in the femur of a rat model during posterolateral spinal fusion. This suggests a role for further clinical evaluation of vitamin D dietary intake during the peri-operative period, with the possibility of avoiding adverse consequences to general bone health. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:1435-1443, 2018.
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