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CLINICAL TRIAL WITH TRICALCIUM PHOSPHATE IN ORTHOPEDIC SURGERY



Abstract

Among the wide variety of bone substitutes presently available, pure β-tricalcium phosphate ceramics have become available (Biosorb®; Aesculap, Tuttlingen). During the first 12 months of a prospective clinical trial, Biosorb® products were implanted in 21 patients. The ceramics were used in a variety of clinical settings, ranging from pelvic osteotomies in children (n=9), to filling of bone cysts or osseous defects (n=4), to dorsal spondylodesis (n=6), as well as for the grafting of pseudarthroses (n=2). Average follow-up period was 13 (6–18) months.

The β-TCP granules, when used as part of a composite graft in combination with autologous bone, were completely resorbed after an average period of 14 weeks, while the cubes required 12 to 15 months. The more massive wedges have shown only a decrease in size and radio density. Due to the ability of the cubes and wedges to bear loads of up to 30 MPa, they were successfully implanted during pelvic osteotomies to augment or completely replace the bicortical grafts. Complications or foreign body reactions were not noted. The osseointegration was found to be favorable for all forms.

In light of the problems associated with autologous and allogeneic grafts, the use of synthetic bone substitutes will continue to increase. The combination of complete resorption, lack of risk of infection, and load sharing ability make the β-tricalcium phosphate implants a valuable addition to the spectrum of bone replacement products presently available. Their use in pediatric orthopedics could help avoid donor site morbidity including contour changes or growth disturbances, while providing a more stable graft. During the first phase of a prospective clinical trial, we have come to the conclusion, that the β-tricalcium phosphate ceramics represent a real alternative to other bone substitutes.