Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts

Schimizzi, Aimee; Wedemeyer, Michelle; Odell, Tim; Thomas, Walter; Mahar, Andrew; Pedowitz, Robert A.

doi:10.1177/0363546506295083

Cited by 44 publications

(52 citation statements)

References 27 publications

(38 reference statements)

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“…The actuator was held at that displacement for 5 min before testing. Specimens were then loaded with a haversine waveform from 50 to 300 n at 0.5 Hz for a total of 250 cycles [18]. Failure tests were then conducted at 50 mm/min (0.83 mm/s) until a substance tear was observed.…”

Section: Methodsmentioning

confidence: 99%

Effect of a novel sterilization method on biomechanical properties of soft tissue allografts

Baldini

Caperton

Hawkins

et al. 2014

Knee Surg Sports Traumatol Arthrosc

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Section: Methodsmentioning

confidence: 99%

Effect of a novel sterilization method on biomechanical properties of soft tissue allografts

Baldini

Caperton

Hawkins

et al. 2014

Knee Surg Sports Traumatol Arthrosc

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“…Medial menisci in the sterile group went through the proprietary BioCleanse 1 sterilization protocol. BioCleanse 1 is a low-temperature chemical sterilization process that uses pressure-vacuum cycling to remove pathogens, blood, and lipids from tissue [15,20,28]. Individually packaged menisci were frozen to -70°C and transported to the test facility on dry ice.…”

Section: Methodsmentioning

confidence: 99%

Performance of a Sterile Meniscal Allograft in an Ovine Model

McNickle¹,

Wang²,

Shewman³

et al. 2009

Clinical Orthopaedics &Amp; Related Research

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Meniscus transplantation is indicated for persistent pain in a meniscectomized knee. Currently, grafts are prepared aseptically, which provides limited protection against donor-derived infection. The performance of a novel, sterilized meniscus was compared with an aseptically prepared one in an experimental model. Twenty-two sheep were divided into three groups: aseptic meniscal allograft, sterile meniscal allograft, and medial meniscectomy. Animals were euthanized 2 and 4 months after surgery. Meniscal assessments included cell viability, histology, and biomechanical testing. Articular cartilage was evaluated through histology and Outerbridge scoring. Aseptic and sterile allografts had cell viabilities of 59.7% and 58.7%, respectively, at 4 months, which was less than native controls. Grafts had decreased compressive strength at 4 months compared with their preimplantation moduli and were weaker than native menisci. In operated knees, the tibial plateau had more severe degenerative changes, although Outerbridge scores were similar between operated groups. Overall, the allografts were similar in their cellularity and biomechanical properties but were inferior to the native tissue at these end points. The severity of chondral damage in the allograft knees could not be distinguished from meniscectomized joints. The sterilization process does not appear to compromise tissue integrity and provides additional allograft safety.

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“…This combination results in the gentle and complete perfusion of the tissue, and removes blood, bone marrow and other unwanted endogenous materials, as well as removes or inactivates pathogenic organisms (Mroz et al 2006;Schimizzi et al 2007). As part of the process, two cleaning reagents, which have been proven to be robust inactivators of enveloped viruses, such as HIV, HBV, and HCV, are used in combination (Horowitz et al 1992;Howett et al 1999).…”

Section: Sterilizationmentioning

confidence: 99%

“…The BioCleanse Ò treated bovine bone material was shown to be incorporated into the bone in a sheep model (Katz et al 2009). This process also produces sterile allografts without reducing the biomechanical properties of bone or soft tissues (Mroz et al 2006;Jones et al 2007;Schimizzi et al 2007;Mikhael et al 2008). …”

Section: Introductionmentioning

confidence: 99%

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

et al. 2010

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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.

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Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts

Abstract: This novel sterilization technique may provide surgeons with potential allograft material with similar biomechanical properties to native tissue.

Cited by 44 publications

References 27 publications

Effect of a novel sterilization method on biomechanical properties of soft tissue allografts

Effect of a novel sterilization method on biomechanical properties of soft tissue allografts

Performance of a Sterile Meniscal Allograft in an Ovine Model

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

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