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      Preservation of allograft bone using a glycerol solution: a compilation of original preclinical research

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      https://www.riss.kr/link?id=A106106044

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      다국어 초록 (Multilingual Abstract)

      Background: Bone allografts are used in many orthopedic procedures to provide structural stability as well as an osteoconductive matrix for bone ingrowth and fusion. Traditionally, bone allografts have been preserved by either freezing or freeze-drying. Each of these preservation methods has some disadvantages: Frozen grafts require special shipping and storage conditions, and freeze-drying requires special lyophilization equipment and procedures that may impact biomechanical integrity. This report describes an alternate type of preservation using glycerol, which allows storage of fully-hydrated tissues at ambient temperature avoiding the potential complications from freeze-drying. Methods: In the in vitro three-point bend test, cortical bone was processed and frozen, freeze-dried, or treated with glycerol-based preservation (GBP). Load was applied to each graft at a rate of 2.71mm/min. The flexural strain, flexural strength, and flexural modulus were then calculated. In the in vitro axial compression test, iliac crest wedges, fibular segments, and Cloward dowels were processed and either freeze-dried or GBP treated. The compressive strength of the grafts were tested at time zero and after real time aging of 1, 4, and 5 years. In the in vivo rat calvarial defect assessment, freeze-dried, frozen, and GBP bone implants were compared after being implanted into a critical sized defect. Samples underwent histological and biomechanical evaluation. Results: Bone grafts subjected to GBP were found to be at least biomechanically equivalent to frozen bone while also being significantly less brittle than freeze-dried bone. GBP-preserved bone demonstrated significantly greater compressive strength than freeze-dried at multiple time points. Preclinical research performed in calvaric defect models found that GBP-preserved bone had similar osteoconductivity and biocompatibility to frozen and freeze-dried samples. Conclusion: Preclinical research demonstrated that glycerol–preservation of bone yields a material that maintains biomechanical strength while eliminating the need for extensive rehydration or thaw periods if used clinically. Additionally, in vivo evidence suggests no negative impact of glycerol-preservation on the ability of bone grafts to successfully participate in new bone formation and fusion.
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      Background: Bone allografts are used in many orthopedic procedures to provide structural stability as well as an osteoconductive matrix for bone ingrowth and fusion. Traditionally, bone allografts have been preserved by either freezing or freeze-dryin...

      Background: Bone allografts are used in many orthopedic procedures to provide structural stability as well as an osteoconductive matrix for bone ingrowth and fusion. Traditionally, bone allografts have been preserved by either freezing or freeze-drying. Each of these preservation methods has some disadvantages: Frozen grafts require special shipping and storage conditions, and freeze-drying requires special lyophilization equipment and procedures that may impact biomechanical integrity. This report describes an alternate type of preservation using glycerol, which allows storage of fully-hydrated tissues at ambient temperature avoiding the potential complications from freeze-drying. Methods: In the in vitro three-point bend test, cortical bone was processed and frozen, freeze-dried, or treated with glycerol-based preservation (GBP). Load was applied to each graft at a rate of 2.71mm/min. The flexural strain, flexural strength, and flexural modulus were then calculated. In the in vitro axial compression test, iliac crest wedges, fibular segments, and Cloward dowels were processed and either freeze-dried or GBP treated. The compressive strength of the grafts were tested at time zero and after real time aging of 1, 4, and 5 years. In the in vivo rat calvarial defect assessment, freeze-dried, frozen, and GBP bone implants were compared after being implanted into a critical sized defect. Samples underwent histological and biomechanical evaluation. Results: Bone grafts subjected to GBP were found to be at least biomechanically equivalent to frozen bone while also being significantly less brittle than freeze-dried bone. GBP-preserved bone demonstrated significantly greater compressive strength than freeze-dried at multiple time points. Preclinical research performed in calvaric defect models found that GBP-preserved bone had similar osteoconductivity and biocompatibility to frozen and freeze-dried samples. Conclusion: Preclinical research demonstrated that glycerol–preservation of bone yields a material that maintains biomechanical strength while eliminating the need for extensive rehydration or thaw periods if used clinically. Additionally, in vivo evidence suggests no negative impact of glycerol-preservation on the ability of bone grafts to successfully participate in new bone formation and fusion.

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      참고문헌 (Reference)

      1 Cammisa FP, "Two-year fusion rate equivalency between Grafton DBM gel and autograft in posterolateral spine fusion : a prospective controlled trial employing a side-by-side comparison in the same patient" 29 (29): 660-666, 2004

      2 Food and Drug Administration, "Title 21 § 182.1320. Glycerin"

      3 Sohoni P, "The effects of a new preservation method on the biomechanics and shelf life of allograft bone" Orthopaedic research Society 2011

      4 Schmitz JP, "The critical size defect as an experimental model for craniomandibulofacial nonunions" 205 : 299-308, 1986

      5 Buser Z, "Synthetic bone graft versus autograft or allograft for spinal fusion : a systematic review" 25 (25): 509-516, 2016

      6 Monje A, "On the feasibility of utilizing allogeneic bone blocks for atrophic maxillary augmentation" 2014 : 814578-, 2014

      7 Jae-Hwi Han, "Is Bone Grafting Necessary in Opening Wedge High Tibial Osteotomy? A Meta-Analysis of Radiological Outcomes" 대한슬관절학회 27 (27): 207-220, 2015

      8 Crouch K, "Inventors; LifeNet health, assignee. Plasticized bone grafts and methods of making and using same"

      9 Wolfinbarger Jr L, "Inventor; Lifenet Research Foundation, assignee. Process and composition for cleaning soft tissue grafts optionally attached to bone and soft tissue and bone grafts produced thereby"

      10 Wolfinbarger Jr L, "Inventor; LifeNet health, assignee. Composition for cleaning bones"

      1 Cammisa FP, "Two-year fusion rate equivalency between Grafton DBM gel and autograft in posterolateral spine fusion : a prospective controlled trial employing a side-by-side comparison in the same patient" 29 (29): 660-666, 2004

      2 Food and Drug Administration, "Title 21 § 182.1320. Glycerin"

      3 Sohoni P, "The effects of a new preservation method on the biomechanics and shelf life of allograft bone" Orthopaedic research Society 2011

      4 Schmitz JP, "The critical size defect as an experimental model for craniomandibulofacial nonunions" 205 : 299-308, 1986

      5 Buser Z, "Synthetic bone graft versus autograft or allograft for spinal fusion : a systematic review" 25 (25): 509-516, 2016

      6 Monje A, "On the feasibility of utilizing allogeneic bone blocks for atrophic maxillary augmentation" 2014 : 814578-, 2014

      7 Jae-Hwi Han, "Is Bone Grafting Necessary in Opening Wedge High Tibial Osteotomy? A Meta-Analysis of Radiological Outcomes" 대한슬관절학회 27 (27): 207-220, 2015

      8 Crouch K, "Inventors; LifeNet health, assignee. Plasticized bone grafts and methods of making and using same"

      9 Wolfinbarger Jr L, "Inventor; Lifenet Research Foundation, assignee. Process and composition for cleaning soft tissue grafts optionally attached to bone and soft tissue and bone grafts produced thereby"

      10 Wolfinbarger Jr L, "Inventor; LifeNet health, assignee. Composition for cleaning bones"

      11 Pinkowski JL, "Human lymphocyte reaction to freezedried allograft and xenograft ligamentous tissue" 17 (17): 595-600, 1989

      12 Kang J, "Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions" 37 (37): 1083-1091, 2012

      13 Burchardt H, "Freeze-dried segmental fibular allografts in azathioprine-treated dogs" (218) : 259-267, 1987

      14 Burchardt H, "Freeze-dried allogeneic segmental cortical-bone grafts in dogs" 60 (60): 1082-1090, 1978

      15 Bottino MC, "Freeze-dried acellular dermal matrix graft : effects of rehydration on physical, chemical, and mechanical properties" 25 (25): 1109-1115, 2009

      16 Graham RS, "Evaluation of glycerol-preserved bone allografts in cervical spine fusion : a prospective, randomized controlled trial" 22 (22): 1-10, 2015

      17 Spicer PP, "Evaluation of bone regeneration using the rat critical size calvarial defect" 7 (7): 1918-1929, 2012

      18 Moore MA, "Decellularization of human dermis using non-denaturing anionic detergent and endonuclease : a review" 16 (16): 249-259, 2015

      19 Rodway I, "Comparison of fusion rates between glycerol-preserved and frozen composite allografts in cervical fusion" 2014 : 960142-, 2014

      20 American Association of Tissue Banks (AATB), "American Association of Tissue Banks (AATB) Annual Survey of Accredited Tissue Banks in the United States" AATB 2007

      21 McGuire DA, "Allograft tissue in ACL reconstruction" 17 (17): 224-233, 2009

      22 Boyce T, "Allograft bone : the influence of processing on safety and performance" 30 (30): 571-581, 1999

      23 Thalgott JS, "A prospective, randomized, blinded, single-site study to evaluate the clinical and radiographic differences between frozen and freeze-dried allograft when used as part of a circumferential anterior lumbar interbody fusion procedure" 34 (34): 1251-1256, 2009

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      학술지 이력
      연월일 이력구분 이력상세 등재구분
      2023 평가예정 해외DB학술지평가 신청대상 (해외등재 학술지 평가)
      2020-01-01 평가 등재학술지 유지 (해외등재 학술지 평가) KCI등재
      2017-01-01 평가 등재학술지 유지 (계속평가) KCI등재
      2013-01-01 평가 등재 1차 FAIL (등재유지) KCI등재
      2010-01-01 평가 등재학술지 유지 (등재유지) KCI등재
      2007-01-01 평가 등재학술지 선정 (등재후보2차) KCI등재
      2006-01-01 평가 등재후보 1차 PASS (등재후보1차) KCI등재후보
      2005-03-28 학회명변경 한글명 : 생체재료학회 -> 한국생체재료학회
      영문명 : 미등록 -> The Korean Society For Biomaterials
      KCI등재후보
      2005-03-28 학술지등록 한글명 : 생체재료학회지
      외국어명 : Biomaterials Research
      KCI등재후보
      2004-07-01 평가 등재후보학술지 선정 (신규평가) KCI등재후보
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      기준연도 WOS-KCI 통합IF(2년) KCIF(2년) KCIF(3년)
      2016 0.32 0.32 0.3
      KCIF(4년) KCIF(5년) 중심성지수(3년) 즉시성지수
      0.26 0.23 0.511 0.11
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