Although osteochondral grafting techniques have nearly been perfected, donor site morbidity still causes concern. A synthetic β-tricalcium phospate cement was used in the attempt to obtain a primary closure of such osteochondral defects, while supplying a scaffold for tissue ingrowth. Twenty merino sheep underwent an osteochondral grafting procedure. The paste-like β-TCP cement was used to fill the ensuing cylindrical, full-thickness defect. Animals were sacrificed after 3 or 6 months. The macroscopic observations revealed neither osteophytes nor synovial proliferation, while demonstrating coverage of the defect with cartilage-like tissue. After 6 months, all defects were covered with a ”neo-cartilage” and the congruity of the joint surface was restored in 6 of 10 animals. A surface depression was found in the remaining cases. A demarkation of the defect border at the interface with the original cartilage could only be seen in 2 instances. The x-rays of the retrieved distal femurs revealed only traces of the dense β-TCP particles. Microradiographs demonstrated the incorporation of the implant. Fluorescent staining showed continuous bone ingrowth. Histologically, masses of unabsorbed TCP were irregularly distributed through-out the defect. Newly formed bone had filled much of the defect. The histological evaluation confirmed that the surface of the cement was covered with a cartilage-like tissue. This study showed, that the newly developed in-situ self-hardening resorbable β-tricalcium phosphate cement is easy to handle, hardens in a clinical-type setting, is bioactive and resorbable. Its osteoconductive effect lead to a restoration of biomechanically stable bone and allows for a normal remodeling process. Biomaterials made of β-TCP promise to play a role as a biodegradable scaffold, allowing osteo-blast ingrowth and cartilagenous resurfacing, while being fully resorbed during the process. The cement may also be used to deliver bioactive agents and cells for defect repair in the near future.
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.
