TREATMENT OF ACUTE FRACTURES WITH A COLLAGEN-CALCIUM PHOSPHATE GRAFT MATERIAL - A RANDOMIZED CLINICAL-TRIAL

A prospective, randomized clinical trial was conducted concurrently at eighteen medical centers in order to compare the safety and efficacy of two types of graft material for the treatment of fractures of long bones: autogenous bone graft obtained from the iliac crest, and a comp osite material composed of purified bovine collagen, a biphasic calciu m-phosphate ceramic, and autogenous marrow, Two hundred and thirteen p atients (249 fractures) were followed for a minimum of twenty-four mon ths to monitor healing and the occurrence of complications. We observe d no significant differences between the two treatment groups with res pect to rates of union (p = 0.94, power = 88 per cent) or functional m easures (use of analgesics, pain with activities of daily living, and impairment in activities of daily living; p > 0.10). The prevalence of complications did not differ between the treatment groups except for the rate Of infection, which was higher in the patients who were manag ed with an autogenous graft. Twelve patients who were managed with a s ynthetic graft had a positive antibody titer to bovine collagen; seven of them agreed to have intradermal challenge with bovine collagen, On e patient had a positive skin response to the challenge but had no com plications with regard to healing of the fracture. We concluded that, for traumatic defects of long bones that necessitate grafting, use of the composite graft material appears to be justified on the grounds of safety, efficacy, and elimination of the increased operative time and risk involved in obtaining an autogenous graft from the iliac crest.