Intraarticular reaction associated with the use of freeze-dried,ethylene oxide-sterilized bone-patella tendon-bone allografts in the reconstruction of the anterior cruciate ligament
Restricted accessOtherFirst published online January, 1990
Intraarticular reaction associated with the use of freeze-dried,ethylene oxide-sterilized bone-patella tendon-bone allografts in the reconstruction of the anterior cruciate ligament
One hundred nine patients over a 3 year period under went reconstruction for chronic ACL ruptures using a freeze-dried, ethylene oxide-sterilized bone-patella ten don-bone allograft. Seven patients (6.4%) developed a characteristic persistent intraarticular reaction. This re action was characterized by persistent synovial effusion with collagenous particulates and cellular inflammatory response. Synovial biopsies in all cases showed a similar chronic inflammatory process, characterized by fibrin, collagen, and phagocytic cells. The intraarticular white cells were predominantly lymphocytes. Removal of the allograft resulted in resolution of the reaction in all of the patients. Three of the seven patients showed HLA conversion. Gas chromatography demonstrated detectable levels of ethylene chlorohydrin, a toxic re action product of ethylene oxide, within the allograft and synovium 14 months following implantation of one graft. These seven cases presented strongly suggest a nonspecific or immune mediated response that must be further delineated. The use of freeze-dried, ethylene oxide-sterilized allografts using standard techniques cannot be recommended for reconstruction of the ACL.
Get full access to this article
View all access options for this article.
References
1.
Abbink EP: Clinical experience in correction of chronic antenor cruciate ligament deficiency with bovine xenografts: A 5-year study, in Fnedman MJ, Ferkel RD (eds): Prosthetic Ligament Reconstruction of the Knee. Philadelphia , WB Saunders Co, 1988 , pp 101-111
2.
Andersen SR Ethylene oxide toxicity A study of tissue reactions to retained ethylene oxide . J Lab Clin Med77346-356, 1971
3.
Baer GM, Shaddock JH, Houff SA, et al Human rabies transmitted by corneal transplant Arch Neurol39: 103-107, 1982
4.
Burwell RG: The fate of freeze-dried bone allografts. Transplant Proc8 (2 Suppl 1). 95-111, 1976
5.
Butler DL, Noyes FR, Grood ES: Ligamentous restraints to antenorposterior drawer in the human knee. A biomechanical study. J Bone Joint Surg62A259-270, 1980
6.
Clancy WG, Nelson DA Jr, Reider B., et al: Antenor cruciate ligament reconstruction using one-third of the patellar tendon augmented by extraarticular tendon transfers. J Bone Joint Surg64A: 352-359, 1982
7.
Cloward RB: Gas-sterilized cadaver bone grafts for spinal fusion operations A simplified bone bank Spine54-10, 1980
8.
Cooper DA, Gold J., Maclean P., et al: Acute AIDS retrovirus infection. Definition of a clinical illness associated with seroconversion Lancet1 (8428): 537-540, 1985
9.
Curtis RJ, DeLee JC, Drez DJ: Reconstruction of the anterior cruciate ligament with freeze-dned fascia lata allografts in dogs A preliminary report Am J Sports Med13: 408-414, 1985
10.
Dolovich J. , Bell B.: Allergy to a product(s) of ethylene oxide gas Demonstration of IgG antibodies and hapten specificity J Allergy Clin Immunol6230-32, 1978
11.
Duffy P., Wolf J., Collins G., et al: Possible person-to-person transmission of Creutzfeldt-Jakob disease. N Engl J Med290. 692-693, 1974
12.
Ehrenberg L. , Hiesche KD, Osterman-Golkar S., et al I. Evaluation of genetic risks of alkylating agents: Tissue doses in the mouse from air contaminated with ethylene oxide Mutat Res24: 83-103, 1974
13.
Elves MW Humoral immune response to allografts of bone Int Arch Allergy Appl Immunol47: 708-715, 1974
14.
Embree JW, Lyon JP, Hine CH: The mutagenic potential of ethylene oxide using the dominant-lethal assay in rats. Toxicol Appl Pharmacol40. 261-267, 1977
Fnedlaender GE: The antigenicity of preserved allografts . Transplant Proc8 (2 Suppl 1): 195-200, 1976
17.
Fnedlaender GE: Current concepts review. Bone-banking J Bone Joint Surg64A: 307-311, 1982
18.
Friedlaender GE, Strong DM, Sell KW: Studies on the antigenicity of bone. I. Freeze-dried and deep-frozen bone allografts in rabbits J Bone Joint Surg58A854-858, 1976
19.
Fukubayashi T. , Torzilli PA, Sherman MF, et al: An in vitro biomechanical evaluation of anterior/posterior motion of the knee Tibial displacement, rotation and torque. J Bone Joint Surg64A. 258-264, 1982
20.
Furman W., Marshall JL, Girgis FG: The anterior cruciate ligament. A functional analysis based on postmortem studies. J Bone Joint Surg58A: 179-185, 1976
21.
Girgis FG, Marshall JL, Monajem A.: The cruciate ligaments of the knee joint. Anatomical, functional and experimental analysis Clin Orthop106: 216-231, 1975
22.
Glousman R., Shields C., Kerlan R., et al: Gore-Tex prosthetic ligament in anterior cruciate deficient knees. Am J Sports Med16: 321-326, 1988
23.
Gode GR, Bhide NK: Two rabies deaths after corneal grafts from one donor Lancet2(8614): 791, 1988
24.
Guess WL: Tissue reactions to 2-chloroethanol in rabbits. Toxicol Appl Pharmacol16: 382-390, 1970
25.
Gunther DA Permeability of packaging materials to ethylene oxide. Bull Parenter Drug Assoc30: 152-156, 1976
26.
Halloran PF , Lee EH, Ziv I., et al: Orthotopic bone transplantation in mice. II. Studies of the alloantibody response. Transplantation27: 420-426, 1979
27.
Hine CH, Rowe VK: Ethylene Oxide, in Patty FA (ed): Industrial Hygiene and Toxicology. New York , Interscience, 1962, pp 1626-1635
28.
Ho DD, Sarngadharan MG, Resnick L., et al: Primary human T-lymphotropic virus type III infection Ann Intern Med103: 880-883, 1985
29.
Hollingsworth RL, Rowe UK, Oyen F., et al: Toxicity of ethylene oxide determined on experimental animals. Arch Industr Health13: 217-227, 1956
30.
Houff SA, Burton RC, Wilson RW, et al: Human-to-human transmission of rabies virus by corneal transplant . N Engl J Med300: 603-604, 1979
31.
Jackson DW, Reiman PR: Principles of arthroscopic anterior cruciate reconstruction, in Jackson DW, Drez D Jr (eds): The Anterior Cruciate Deficient Knee-New Concepts m Ligament Repair. St. Louis, CV Mosby Co, 1987, pp 273-285
32.
Jackson DW, Grood ES, Arnoczky SP, et al: Freeze dried anterior cruciate ligament allografts. Preliminary studies in a goat model. Am J Sports Med15: 295-303, 1987
33.
Jackson DW, Grood ES, Arnoczky SP, et al: Cruciate reconstruction using freeze dried anterior cruciate ligament allograft and a ligament augmentation device (LAD) An experimental study in a goat model. Am J Sports Med15. 528-538, 1987
34.
Jackson DW, Grood ES, Wilcox P., et al: The effects of processing techniques on the mechanical properties of bone-anterior cruciate ligament-bone allografts An experimental study in goats Am J Sports Med16:101-105, 1988
35.
Jackson DW, Jennings LD, Maywood RM, et al Magnetic resonance imaging of the knee. Am J Sports Med16: 29-38, 1988
36.
Jordy A., Hoff-Jorgensen R., Flagstad A., et al Virus inactivation by ethylene oxide containing gases. Acta Vet Scand16379-387, 1975
37.
Kennedy JC, Roth JC, Mendenhall HV, et al: lntraarticular replacement in the anterior cruciate ligament deficient knee Am J Sports Med8:1-8, 1980
38.
Krackow KA, Brooks RL: Optimization of knee ligament position for lateral extra-articular reconstruction . Am J Sports Med11. 293-302, 1983
39.
Lipke JM, Janecki CJ, Nelson CL, et al: The role of incompetence of the anterior cruciate and lateral ligaments in anterolateral and anteromedial instability. A biomechanical study of cadaver knees. J Bone Joint Surg63A. 954-960, 1981
40.
Markolf KL, Kocahn A., Amstutz HC: Measurement of knee stiffness and laxity in patients with documented absence of the anterior cruciate ligament J Bone Joint Surg66A: 242-253, 1984
41.
Malaveille C., Bartsch H., Barbin A., et al: Mutagenicity of vinyl chloride, chloroethyleneoxide, chloroacetaldehyde and chloroethanol . Biochem Biophys Res Commun63: 363-370, 1975
42.
Marshall JL , Warren RF, Wickiewicz TL, et al: The anterior cruciate ligament A technique of repair and reconstruction. Clin Orthop143: 97-106, 1979
43.
McGunnigle RG, Renner JA, Romano SJ, et al: Residual ethylene oxide: Levels in medical grade tubing and effects of an in vitro biologic system. J Biomed Mater Res9. 273-283, 1975
44.
Miller WV, Walsh JH, Paskin S. Ethylene oxide sterilization to prevent post-transfusion hepatitis . N Engl J Med280. 386, 1969
45.
Noyes FR, Butler DL, Paulos LE, et al Intraarticular cruciate ligament reconstruction Clin :Orthop172: 71-77, 1983
46.
Noyes FR, McGinnis GH, Grood ES: The variable functional disability of the anterior cruciate ligament-deficient knee Orthop Clin North Am16: 47-67, 1985
47.
Paulos LE, Rosenberg TD, Gurley WD: Anterior cruciate ligament allografts, in Fnedman MJ, Ferkel RD (eds): Prosthetic Ligament Reconstruction of the Knee. Philadelphia , WB Saunders Co, 1988 , pp 186-192
48.
Phillips CR: Gaseous sterilization, in Block SS (ed): Disinfection, Sterilization and Preservation. Second edition. Philadelphia, Lea and Febiger Co , 1977, pp 592-610
49.
Poothullil J., Shimizu A., Day RP, et al: Anaphylaxis from the product(s) of ethylene oxide gas. Ann Intern Med82: 58-60, 1975
50.
Prolo DJ, Oklund SA: Sterilization of bone by chemicals, in Friedlaender GE, Mankin HJ, Sell KW (eds): Osteochondral Allografts: Biology, Banking and Clinical Applications. Boston, Little, Brown and Co, 1983, pp 233-238
51.
Prolo DJ, Pedrotti PW, White DH: Ethylene oxide sterilization of bone, dura matter, and fascia lata for human transplantation. Neurosurgery6: 529-539, 1980
52.
Savelyev VI : The application of gaseous ethyleneoxide for sterilization of tissue grafts, obtained without maintaining sterile conditions . Acta Chir Plast (Praha)17: 198-204, 1975
53.
Snyder CC, Wardlaw E., Kelly N.: Gas sterilization of cartilage and bone implants. Plast Reconstr Surg28: 568-576, 1961
54.
Stevenson S. : The immune response to osteochondral allografts in dogs. J Bone Joint Surg69A: 573-582, 1987
55.
Tomford WW, Doppelt SH, Mankin HJ, et al: 1983 bone bank procedures. Clin Orthop174: 15-21, 1983
56.
Tucker J., Ludlam CA, Craig A., et al: HTLV-III infection associated with glandular fever-like illness in a hemophiliac. Lancet1 (8428): 585, 1985
57.
United States Department of Health and Human Services, Public Health Services, Centers for Disease Control: Perspectives on the control of viral hepatitis, type B. Morbidity Mortality Weekly Rep (Suppl) 25: 3-10, 1976
58.
United States Department of Health, Education and Welfare, Food and Drug Administration: Ethylene oxide, ethylene chlorohydrin and ethylene glycol Proposed maximum residue limits and maximum level of exposure. Federal Register43: 27474-27483, 1978
59.
Woods GW: Synthetics in anterior cruciate ligament reconstruction: A review . Orthop Clin North Am16: 227-235, 1985
