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Gregory B Maletis, Jason Chen, Maria C S Inacio, Rebecca M Love, Tadashi T Funahashi
BACKGROUND: The optimal graft for anterior cruciate ligament reconstruction (ACLR) remains controversial. PURPOSE: To compare the risk of aseptic revision between bone-patellar tendon-bone (BPTB) autografts, hamstring autografts, and soft tissue allografts. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Prospectively collected ACLR cases reconstructed with BPTB autografts, hamstring autografts, and soft tissue allografts were identified using the Kaiser Permanente ACLR Registry...
July 2017: American Journal of Sports Medicine
Troy A Roberson, Jeffrey T Abildgaard, Douglas J Wyland, Paul C Siffri, Stephen P Geary, Richard J Hawkins, John M Tokish
BACKGROUND: The processing of allograft tissues in anterior cruciate ligament (ACL) reconstruction continues to be controversial. While high-dose irradiation of grafts has received scrutiny for high failure rates, lower dose irradiation and "proprietary-based" nonirradiated sterilization techniques have become increasingly popular, with little in the literature to evaluate their outcomes. Recent studies have suggested that the specifics of allograft processing techniques may be a risk factor for higher failure rates...
November 2017: American Journal of Sports Medicine
Henry B Colaço, Breck R Lord, Diane L Back, Andrew J Davies, Andrew A Amis, Adil Ajuied
Xenograft tendons have been used in few human studies, with variable results. With the advent of novel tissue processing techniques, which may mitigate against an immune-mediated rejection response without adversely affecting mechanical properties, there may now be a clinical role for xenograft tendons, particularly in knee ligament reconstruction. We hypothesize that 'BioCleanse®' processed bovine extensor digitorum medialis (EDM) tendons exhibit favorable time-zero pre-implantation biomechanical characteristics when compared to both unprocessed bovine EDM tendons and BioCleanse® processed human cadaveric allograft tibialis anterior tendons...
February 28, 2017: Journal of Biomechanics
J Mohr, M Germain, M Winters, S Fraser, A Duong, A Garibaldi, N Simunovic, D Alsop, D Dao, R Bessemer, O R Ayeni
Musculoskeletal allografts are typically disinfected using antibiotics, irradiation or chemical methods but protocols vary significantly between tissue banks. It is likely that different disinfection protocols will not have the same level of microorganism kill; they may also have varying effects on the structural integrity of the tissue, which could lead to significant differences in terms of clinical outcome in recipients. Ideally, a disinfection protocol should achieve the greatest bioburden reduction with the lowest possible impact on tissue integrity...
December 2016: Cell and Tissue Banking
I Magiopoulos, J S McQuillan, C L Burd, M Mowlem, M-N Tsaloglou
Direct measurement and sampling of pristine environments, such as subglacial lakes, without introducing contaminating microorganisms and biomolecules from the surface, represents a significant engineering and microbiological challenge. In this study, we compare methods for decontamination of titanium grade 5 surfaces, the material extensively used to construct a custom-made probe for reaching, measuring and sampling subglacial Lake Ellsworth in West Antarctica. Coupons of titanium were artificially contaminated with Pseudomonas fluorescens bacteria and then exposed to a number of decontamination procedures...
April 2016: Journal of Microbiological Methods
Samir G Tejwani, Jason Chen, Tadashi T Funahashi, Rebecca Love, Gregory B Maletis
BACKGROUND: Allograft tissue is a common graft choice for anterior cruciate ligament reconstruction (ACLR). Allograft sterilization methods vary widely across numerous commercial tissue vendors. Multiple studies, despite being limited in sample size, have suggested a higher rate of clinical failure associated with the use of allograft tissue in ACLR when compared with autograft. PURPOSE: To examine the association of graft processing techniques, patient characteristics, and graft type with risk of revision surgery after allograft ACLR...
November 2015: American Journal of Sports Medicine
Peter A Indelicato, Michael G Ciccotti, Joel Boyd, Laurence D Higgins, Benjamin S Shaffer, C Thomas Vangsness
PURPOSE: To compare the clinical outcomes of bone-patellar tendon-bone (BTB) allografts processed via a novel sterilization system with the traditional aseptically processed BTB allografts for anterior cruciate ligament (ACL) reconstruction. METHODS: A total of 67 patients undergoing ACL reconstruction at 6 independent investigation sites were randomized into one of two intervention groups, BioCleanse-sterilized or aseptic BTB allografts. Inclusion criteria included an acute, isolated, unilateral ACL tear, and exclusion criteria included prior ACL injury, multi-ligament reconstruction, and signs of degenerative joint disease...
September 2013: Knee Surgery, Sports Traumatology, Arthroscopy: Official Journal of the ESSKA
Bryan P Conrad, Matthew Rappé, MaryBeth Horodyski, Kevin W Farmer, Peter A Indelicato
One major concern regarding soft tissue allograft use in surgical procedures is the risk of disease transmission. Current techniques of tissue sterilization, such as irradiation have been shown to adversely affect the mechanical properties of soft tissues. Grafts processed using Biocleanse processing (a proprietary technique developed by Regeneration Technologies to sterilize human tissues) will have better biomechanical characteristics than tissues that have been irradiated. Fifteen pairs of cadaveric Achilles tendon allografts were obtained and separated into three groups of 10 each...
September 2013: Cell and Tissue Banking
Lisa F Dawson, Esmeralda Valiente, Elizabeth H Donahue, George Birchenough, Brendan W Wren
The increased prevalence of Clostridium difficile infection (CDI) has coincided with enhanced transmissibility and severity of disease, which is often linked to two distinct clonal lineages designated PCR-ribotype 027 and 017 responsible for CDI outbreaks in the USA, Europe and Asia. We assessed sporulation and susceptibility of three PCR-ribotypes; 012, 017 and 027 to four classes of disinfectants; chlorine releasing agents (CRAs), peroxygens, quaternary ammonium compounds (QAC) and biguanides. The 017 PCR-ribotype, showed the highest sporulation frequency under these test conditions...
2011: PloS One
Nathan Kemper, Noel Davison, Daniel Fitzpatrick, Rebecca Marshall, Albert Lin, Katherine Mundy, Ronald R Cobb
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...
November 2011: Cell and Tissue Banking
James Reid, Robby Sikka, William Tsoi, Steven J Narvy, Thomas Hedman, Thay Q Lee, C Thomas Vangsness
Novel allograft processing methods are available from tissue banks to decrease disease transmission. This study evaluated the effects of 3 of these techniques on the initial mechanical properties of bone-patellar tendon-bone (BPTB) allografts: (1) aseptic harvest with low-dose radiation processing, (2) BioCleanse Tissue Processing System, and (3) Clearant Process. Ten-mm BPTB allografts were potted in an MTS 858 machine (MTS Systems Corp, Eden Prairie, Minnesota), cycled, and loaded to failure at a strain rate of 100%/s...
April 2010: Orthopedics
Peter Supronowicz, Rasa Zhukauskas, Amanda York-Ely, Winston Wicomb, Taili Thula, Laraine Fleming, Ronald R Cobb
BACKGROUND: This study evaluates the efficacy of removal of xeno-antigens from bovine bone using a patented BioCleanse process for decellularization of allograft tissues for clinical implantation. BioCleanse deploys a combination of chemicals and several high pressure rinses to achieve standardized sterility assurance levels. This method produces sterile grafts without reducing allograft bone biomechanical properties and effectively removes cells, lipids, and other sources of antigenic material from human allografts for clinical use...
November 2008: Xenotransplantation
Mark M Mikhael, Paul M Huddleston, Mark E Zobitz, Quingshan Chen, Kristin D Zhao, Kai-Nan An
Infectious disease transmission through the use of human donor allografts can be a catastrophic complication in an otherwise straightforward surgical procedure. The use of bone allograft in reconstructive orthopedic surgeries is increasing, yet severe complications, including death, can result if the transplanted tissues transmit a communicable disease to the tissue recipient. The BioCleanse tissue sterilization process is a fully automated, low-temperature chemical sterilization process that renders allograft tissue sterile...
September 18, 2008: Journal of Biomechanics
David B Jones, Paul M Huddleston, Mark E Zobitz, Michael J Stuart
PURPOSE: We tested the hypothesis that the preimplantation mechanical properties of BioCleanse-treated bone-patellar tendon-bone (BPTB) allografts are not significantly different from those of untreated specimens. METHODS: For this controlled laboratory study, specimens were harvested as central third or hemi-BPTB units from both knees of 17 cadaveric tissue donors (11 men and 6 women) aged 19 to 88 years. Donor-matched specimens (20 per group) were randomly assigned to either BioCleanse-treated or untreated control groups...
April 2007: Arthroscopy: the Journal of Arthroscopic & related Surgery
Aimee Schimizzi, Michelle Wedemeyer, Tim Odell, Walter Thomas, Andrew T Mahar, Robert Pedowitz
BACKGROUND: Allograft anterior cruciate ligament reconstruction provides benefits such as earlier return to activities and less pain, but concerns remain regarding potential infection and biomechanical stability. HYPOTHESIS: There is no difference in biomechanical properties of soft tissue allografts treated with the Biocleanse tissue sterilization process compared with irradiated and fresh-frozen allografts. STUDY DESIGN: Controlled laboratory study...
April 2007: American Journal of Sports Medicine
Thomas E Mroz, Eric L Lin, Matthew C Summit, John R Bianchi, Jim E Keesling, Michael Roberts, C Thomas Vangsness, Jeffrey C Wang
BACKGROUND CONTEXT: Several methods to sterilize allograft bone exist, including gamma irradiation and freeze-drying, which can alter the mechanical properties of the graft. Efforts are under way to develop a method for processing osseous allograft that maintains structural integrity. Herein is presented one such method. PURPOSE: To analyze the mechanical properties, compared with nontreated controls, of a novel sterilization process for allograft cortical bone...
January 2006: Spine Journal: Official Journal of the North American Spine Society
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