Effects of Hydrogen Peroxide Cleaning Procedures on Bone Graft Osteoinductivity and Mechanical Properties
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Cell and Tissue Banking (2005) 6:287–298 DOI 10.1007/s10561-005-3148-2
Effects of hydrogen peroxide cleaning procedures on bone graft osteoinductivity and mechanical properties DePaula C.A.1,*, Truncale K.G.1, Gertzman A.A.1, Sunwoo M.H.1 and Dunn M.G.2 1
Musculoskeletal Transplant Foundation, Edison, 08837, NJ, USA; 2University of Medicine and Dentistry of New Jersey - Robert Wood Johnson Medical School, New Brunswick NJ, USA; *Author for correspondence (e-mail: [email protected]; phone: +732-661-2261; fax: +732-661-2309)
Received 7 April 2005; accepted in revised form 9 September 2005
Key words: Allograft, Bone, Disinfection, Mechanical stress, Osteoinductivity
Abstract Bone allografts are frequently used during orthopaedic trauma cases or other reconstructive procedures. Most allografts are processed and cleaned before use. Our goals were to determine if an improved cleaning procedure compromises the strength or osteoinductivity of a graft. We compared our improved cleaning procedure to our standard cleaning procedure on cortical bone allograft. The cleaning procedures are generally composed of a series of chemical steps with nonionic detergents, hydrogen peroxide, and alcohol under time and temperature control, subjected to ultrasonic agitation. We tested the compressive strength, impact strength, and shear strength following the standard and improved cleaning procedures. Osteoinductivity was tested in 4 groups, using the improved cleaning procedure with four different hydrogen peroxide cleaning times: 0, 1, 3, and 5 h. Osteoinductivity was evaluated in vivo, using a 28-day implant in the hamstring muscle of an athymic, nude mouse. Results demonstrated that osteoinductivity is maintained with cleaning in hydrogen peroxide for up to 1 h, and that compressive strength, impact strength, and shear strength were all unaffected by the improved cleaning procedure. The improved cleaning procedure therefore did not compromise the strength or osteoinductivity of cortical bone allografts in comparison to the standard procedure.
Introduction Bone allografts are vital for skeletal deficiencies that occur from trauma, joint reconstruction, or other reconstructive procedures. There were over 986,000 bone grafts distributed in 2002 (American Association of Tissue Banks 2004), and their usage is growing. Today, most cortical bone allografts are processed and cleaned before use (Mankin 1993; Boyce et al. 1999; Tomford and Mankin 1999). Allografts are typically cleaned physically and chemically to sterilize or help reduce the bioburden, and reduce the cellular antigens in the grafts. Chemical
cleaning of grafts provides an additional level of safety over and above donor screening (AATB and FDA donor screening rules.), but it is important not to jeopardize the graft by cleaning it. Commonly used chemical methods employ aqueous solutions of detergents or surfactants, hydrogen peroxide or other peroxide, organic solvents, acids, and alcohol. Frequently, the chemical methods are used in combination with mechanical methods, such
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