Remodeling of ACL Allografts is Inhibited by Peracetic Acid Sterilization

Sterilization of allografts for anterior cruciate ligament (ACL) reconstruction has become an important prerequisite to prevent disease transmission. However, current sterilization techniques impair the biological or mechanical properties of such treated grafts. Peracetic acid (PAA) has been successfully used to sterilize bone allografts without these disadvantages and does not impair the mechanical properties of soft tissue grafts in vitro. We asked whether PAA sterilization would influence recellularization, restoration of crimp length and pattern, and revascularization of ACL grafts during early healing. We used an in vivo sheep model for open ACL reconstruction. We also correlated the histologic findings with the restoration of anteroposterior stability and structural properties during load-to-failure testing. PAA slowed remodeling activity at 6 and 12 weeks compared to nonsterilized allografts and autografts. The mechanical properties of PAA grafts were also reduced compared to these control groups at both time points. We conclude PAA sterilization currently should not be used to sterilize soft tissue grafts typically used in ACL reconstruction.

[1]  A. Weiler,et al.  Tendon healing in a bone tunnel. Part I: Biomechanical results after biodegradable interference fit fixation in a model of anterior cruciate ligament reconstruction in sheep. , 2002, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[2]  G. Poehling,et al.  Cost comparison of anterior cruciate ligament reconstruction: autograft versus allograft. , 2005, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[3]  U. Göbel,et al.  Validation of the sterilization procedure of allogeneic avital bone transplants using peracetic acid-ethanol. , 2001, Biologicals : journal of the International Association of Biological Standardization.

[4]  Norbert P Südkamp,et al.  Tendon healing in a bone tunnel. Part II: Histologic analysis after biodegradable interference fit fixation in a model of anterior cruciate ligament reconstruction in sheep. , 2002, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[5]  A. Weiler,et al.  Biomechanical comparison of human bone-patellar tendon-bone grafts after sterilization with peracetic acid ethanol , 2004, Cell and Tissue Banking.

[6]  R. Siebold,et al.  Primary ACL reconstruction with fresh-frozen patellar versus Achilles tendon allografts , 2003, Archives of Orthopaedic and Trauma Surgery.

[7]  D. Butler,et al.  The Effect of Gamma Irradiation on Anterior Cruciate Ligament Allograft Biomechanical and Biochemical Properties in the Caprine Model at Time Zero and at 6 Months after Surgery , 2006, The American journal of sports medicine.

[8]  A. Weiler,et al.  Biomechanical Properties and Vascularity of an Anterior Cruciate Ligament Graft can be Predicted by Contrast-Enhanced Magnetic Resonance Imaging , 2001, The American journal of sports medicine.

[9]  J. Irrgang,et al.  Allograft Versus Autograft Anterior Cruciate Ligament Reconstruction: 3- to 5-Year Outcome , 1996, Clinical orthopaedics and related research.

[10]  D. Prolo,et al.  Ethylene oxide sterilization of bone, dura mater, and fascia lata for human transplantation. , 1980, Neurosurgery.

[11]  Freddie H. Fu,et al.  The induction of IL-1 by freeze-dried ethylene oxide-treated bone-patellar tendon-bone allograft wear particles: an in vitro study. , 1993, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[12]  R. von Versen,et al.  [Experimental studies of the sterilization of transplantation material with peracetic acid]. , 1984, Zeitschrift fur experimentelle Chirurgie, Transplantation, und kunstliche Organe : Organ der Sektion Experimentelle Chirurgie der Gesellschaft fur Chirurgie der DDR.

[13]  R. Warren,et al.  Tendon-healing in a bone tunnel. A biomechanical and histological study in the dog. , 1993, The Journal of bone and joint surgery. American volume.

[14]  E. Grood,et al.  A comparison of patellar tendon autograft and allograft used for anterior cruciate ligament reconstruction in the goat model , 1993, The American journal of sports medicine.

[15]  W. Akeson,et al.  The phenomenon of “Ligamentization”: Anterior cruciate ligament reconstruction with autogenous patellar tendon , 1986, Journal of orthopaedic research : official publication of the Orthopaedic Research Society.

[16]  S. Rodeo,et al.  Soft Tissue Allografts for Knee Reconstruction in Sports Medicine , 2002, Clinical orthopaedics and related research.

[17]  D G Ellis,et al.  Cross-sectional area measurements for tendon specimens: a comparison of several methods. , 1969, Journal of biomechanics.

[18]  C. Harner,et al.  Clinical outcomes of allograft versus autograft in anterior cruciate ligament reconstruction. , 2007, Clinics in sports medicine.

[19]  U. Göbel,et al.  Peracetic acid-ethanol treatment of allogeneic avital bone tissue transplants--a reliable sterilization method. , 2003, Annals of transplantation.

[20]  J. Bellemans,et al.  Graft selection in anterior cruciate ligament reconstruction – prospective analysis of patellar tendon autografts compared with allografts , 1997, International Orthopaedics.

[21]  A. Scheller,et al.  The Biomechanical Effects of Low-Dose Irradiation on Bone-Patellar Tendon-Bone Allografts , 2004, The American journal of sports medicine.

[22]  D. Drez,et al.  Anterior cruciate ligament reconstruction using freeze-dried, ethylene oxide-sterilized, bone-patellar tendon-bone allografts , 1991, The American journal of sports medicine.

[23]  D. E. Cooper,et al.  Contaminated patellar tendon grafts: incidence of positive cultures and efficacy of an antibiotic solution soak--an in vitro study. , 1991, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[24]  M. Spector,et al.  Fibroblast distribution in the anteromedial bundle of the human anterior cruciate ligament: The presence of α‐smooth muscle actin‐positive cells , 1999, Journal of orthopaedic research : official publication of the Orthopaedic Research Society.

[25]  Update: allograft-associated bacterial infections--United States, 2002. , 2002, MMWR. Morbidity and mortality weekly report.

[26]  A. Weiler,et al.  Fresh-frozen free-tendon allografts versus autografts in anterior cruciate ligament reconstruction: delayed remodeling and inferior mechanical function during long-term healing in sheep. , 2008, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[27]  J. Delee,et al.  Contaminated anterior cruciate ligament grafts: the efficacy of 3 sterilization agents. , 2000, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[28]  J. Carey.  The Anterior Cruciate Ligament: Reconstruction and Basic Science , 2008 .

[29]  M. Kainer,et al.  Allograft Transplantation in the Knee: Tissue Regulation, Procurement, Processing, and Sterilization , 2003, The American journal of sports medicine.

[30]  W. Shelton,et al.  Autograft versus allograft anterior cruciate ligament reconstruction. , 1997, Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association.

[31]  A. Weiler,et al.  Endoligamentous Revascularization of an Anterior Cruciate Ligament Graft , 2003, Clinical orthopaedics and related research.

[32]  A. Weiler,et al.  The extracellular remodeling of free-soft-tissue autografts and allografts for reconstruction of the anterior cruciate ligament: a comparison study in a sheep model , 2008, Knee Surgery, Sports Traumatology, Arthroscopy.

[33]  N. Südkamp,et al.  Tendon healing in a bone tunnel. Part II , 2002 .

[34]  D. Butler.  Anterior cruciate ligament: Its normal response and replacement , 1989, Journal of orthopaedic research : official publication of the Orthopaedic Research Society.

[35]  W. Grana,et al.  Tendon-to-bone healing of a semitendinosus tendon autograft used for ACL reconstruction in a sheep model. , 2000, The American journal of knee surgery.