SUMMARYI n this paper the factors which contribute importantly to incompatibility and functional failure of implant materials are examined. The interaction of these criteria in the etiology of implant failure is discussed in terms of the host response to an inert implant and the modulation of this response in the presence of cytotoxic sequellae. Cellular injury either of traumatic or biochemical origin is seen to stimulate sequestration of the offending implant by fibrous tissue. Difficulties associated with routine quantification of such response by animal implantation studies have led to development of rapid in vitro techniques to predict the quantity and cytotoxicity of moeities released by an implant. These techniques are based on infrared analysis and primary mammalian tissue culture with a pseudo body fluid to which materials are exposed a t elevated temperature. The protocols allow formulation of rational criteria for rejection of candidate materials for clinical implantation and acceptance for definitive preclinical animal implant studies. The procedures are applicable for routine monitoring of materials accepted for fabrication of prototype or production implants and of fabricated prostheses.
Substantial clinical interest has developed in the use of in situ curing acrylic polymer for stabilization of joint prostheses. This study used canines to determine the local-tissue effects from heat and unreacted monomer and the distal effects due to monomer leakage into the venous circulation. These were also studied in humans. The results show monomer levels as high as 1.3 mg % in the central venous system. In canines, levels of 5 mg % caused local pulmonary hemorrhage; however, no long-term morbidity was found at levels as high as 50 mg %. Thermal trauma is substantial at the implant/tissue interface. Fibrous tissue sequestration occurs and may lessen the long-term prosthesis stabilization. The mechanical properties of the polymer are substantially compromised by inclusions of blood at implantation.
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