Metal ion release from titanium-based prosthetic segmental replacements of long bones in baboons: a long-term study.

Forty-five baboons that had received titanium-based fiber metal composite segmental bone replacements were studied along with 13 controls without implants. Thirty-eight baboons with implants were sacrificed, and titanium, aluminum, and vanadium levels were assayed in homogenized lung, kidney, spleen, liver, adjacent muscle, and regional lymph nodes. In seven living baboons with implants, blood and urine samples were obtained for trace metal analysis as well as for biochemical and hematological profiles. In the 38 sacrificed baboons with implants, increased titanium levels were noted in the lungs, spleen, adjacent muscle (quadriceps, soleus, and triceps), and regional lymph nodes (inguinal, axillary, and popliteal) in comparison to those of six sacrificed controls without implants. In addition, vanadium was significantly elevated in the lungs of some animals, while aluminum increases were noted in adjacent muscle (quadriceps, soleus, and triceps), lung, and regional lymph nodes (inguinal, axillary, and popliteal). In the seven living baboons with implants, a sixfold increase (p less than 0.0005) in the urine titanium level was noted in comparison to that of seven living controls without implants. Additionally, elevated aluminum levels were found in the serum (p less than 0.0005) of the group with implants. Biochemical and hematological studies did not indicate statistically significant differences in serum electrolytes, in liver and renal function tests, or in complete blood counts between the seven living baboons with implants and their controls.