A rabbit ulnar non-union model was used to evaluate the effect of
recombinant human osteogenic protein-1 on the healing of a large segmental
osteoperiosteal defect. A 1.5-centimeter segmental defect was created in
the mid-part of the ulnar shaft of adult rabbits. The defect was filled
with an implant containing either recombinant human osteogenic protein-1 or
naturally occurring bovine osteogenic protein. The recombinant human
osteogenic protein-1 implants consisted of a carrier of 125 milligrams of
demineralized, guanidine-extracted, insoluble rabbit bone matrix (the
collagen carrier), reconstituted with 3.13, 6.25, 12.5, twenty-five, fifty,
100, 200, 300, or 400 micrograms of recombinant human osteogenic protein-1.
Animals that received recombinant human osteogenic protein-1 were compared
with animals that received an implant of 250 micrograms of a preparation of
naturally occurring bovine osteogenic protein mixed with the collagen
carrier. Limbs that served as controls received either the collagen carrier
alone or no implant at all. The treated and the untreated defects were
examined radiographically and histologically at eight or twelve weeks after
implantation. Mechanical testing was performed on six animals. All implants
of recombinant human osteogenic protein-1, except for those containing 3.13
micrograms of the substance, induced complete radiographic osseous union
within eight weeks. The defects that were treated with an implant of bovine
osteogenic protein also healed within this time-period. The bone induced by
both types of implants had new cortices with advanced remodeling and marrow
elements. Histological evaluation of this new bone at eight weeks
postoperatively revealed primarily lamellar bone, with the formation of new
cortices and normal-appearing marrow elements. The average torsional
strength and energy-absorption capacity of the union induced by recombinant
human osteogenic protein-1 was comparable with that of intact bone. The
control defects that had been implanted with collagen carrier alone and
those with no implant showed no bridging of the defect.