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 underwent reconstruction for chronic ACL ruptures using a freeze-dried, ethylene oxide-sterilized bone-patella tendon-bone allograft. Seven patients (6.4%) developed a characteristic persistent intraarticular reaction. This reaction 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 reaction 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.