Characterization of the mechanical properties of bovine cortical bone treated with a novel tissue sterilization process

Abstract

Over the past decade chemical processing and engineering of musculoskeletal tissue (tendon and bone) has improved dramatically. The use of bone allograft and xenograft in reconstructive orthopedic and maxillofacial surgeries is increasing, yet severe complications can occur if the material is contaminated in any way. A novel tissue sterilization process, BioCleanse®, has been developed to clean and sterilize musculoskeletal tissue for implantation. The present study was designed to determine the effect of this novel cleaning process on the biomechanical properties of bovine cortical bone prior to implantation. The mechanical properties of treated bovine bone material were compared to human samples with respect to failure under compression, shear and three-point bending. The data demonstrate that bovine bone treated with the novel sterilization procedure has favorable biomechanical properties compared to that of human bone treated in a similar fashion.

A Decellularized Porcine Xenograft-Derived Bone Scaffold for Clinical Use as a Bone Graft Substitute: A Critical Evaluation of Processing and Structure

“…Although peracetic acid (PAA) is a weak acid, it does demineralize bone to a small extent which softens the structure, makes it tougher, and decreases elastic modulus [ 62 ]. Lyophilization of tissues has also been shown to compromise mechanical strength [ 62 , 63 , 64 ] and may have altered the elastic modulus in the final stage of scaffold production. When lyophilized specimens are rehydrated, as we did before destructive mechanical testing, they typically lose 20% stiffness and 18.9% ultimate strength [ 63 ].…”

“…Specimens were soaked in normal saline for two h at room temperature prior to mounting them between stainless steel platens for axial compression testing on a material testing machine (MTS) (Instron ® , Norwood, MA, USA). Mounted specimens were preloaded to 5 N in a 2 kN load cell and compressed with a crosshead speed of 0.5 mm/s until fracture or 80% strain was reached [ 64 , 81 , 82 ]. Ultimate stress and strain were calculated from the first peak of the generated stress-strain curve (Bluehill ® Software, Instron, Norwood, MA, USA) while Young’s modulus was derived from the slope of the stress-strain curve’s linear portion.…”

Comparative Biomechanical and Microstructural Analysis of Native versus Peracetic Acid-Ethanol Treated Cancellous Bone Graft

“…In contrast, other studies demonstrated no influence on mechanical properties after chemical disinfection [45, 47]. However, it is important to point out that the authors in those studies investigated the influence of treatment on cortical bone.…”

“…Using cortical human bone allografts, however, Mikhael and coauthors found no alteration in the biomechanical properties by chemical disinfection alone, chemical treatment and terminal disinfection by gamma irradiation, and chemical disinfection and lyophilization [45]. Kemper and coworkers observed also no effect on the biomechanical properties testing cortical bovine bone treated with a low temperature chemical disinfection process with alternating cycles of vacuum and pressure [46] compared to untreated specimens [47]. The use of ethylene oxide for chemical disinfection has been effectively questioned regarding osteoinductive properties by Munting and coworkers [24].…”

Current Stage of Marine Ceramic Grafts for 3D Bone Tissue Regeneration

“…A good number of xenografts are obtained after bone tissue treatment with the BioCleanse® process. This process consists of the tissue sterilization and cleansing procedure using low temperature by combining mechanical and chemical processes removing cells, lipids, and other sources of antigenic material [37,38]. However, other companies decide to use their proprietary manufacturing process.…”