Study design: Posterolateral lumbar transverse process fusion using recombinant human bone morphogenetic protein (rhBMP)-2 carried by sintered bovine bone and Type I collagen complex was compared with fusion achieved using autogeneous bone graft or sintered bovine bone alone.
Objectives: This study examined the efficacy of sintered bovine bone coated with Type I collagen as a carrier of rhBMP-2 for lumbar intertransverse process arthrodesis.
Summary of background data: Posterolateral intertransverse process arthrodesis using osteoinductive growth factors is performed experimentally in the lumbar spine. The previous studies revealed the efficacy of osteoinductive factors applied to carriers having no bony structures, such as collagen sheet or polylactic acid polymer, for the spinal fusion. However, in their studies, a large amount of osteoinductive proteins have been applied for the spinal fusion. We used the sintered bovine bone "True Bone Ceramics" (TBC; Koken Co., Tokyo, Japan) coated with type I collagen as the carrier. True Bone Ceramics is the only biomaterial possessing a natural trabecular structure and an organized crystal of bone minerals.
Methods: Twenty-two adult rabbits underwent bilateral lumbar intertransverse process arthrodesis at L4-L5. The animals were divided into four groups and had materials implanted as follows: autologous bone group, grafted autologous corticocancellous bone harvested from the posterior iliac crest; implanted TBC group; TBC collagen group, implanted TBC coated with Type I collagen infiltrating into the porous space; and BMP group, implanted sintered bovine bone coated with Type I collagen infiltrated with 100 micrograms of rhBMP-2. Spinal fusion was evaluated by radiographic analysis, manual palpation, biomechanical testing, and histologic examination 6 weeks after surgery.
Results: Two rabbits were killed because of infection and lumbar plexus palsy. Radiographs of the BMP group showed a homogeneous fusion mass at the intertransverse area, and stability was confirmed by dynamic radiographs at 3 and 6 weeks after surgery. In the BMP group, a bony mass in the intertransverse area was more prominent than in the other groups. The BMP group had a higher fusion rate based on manual palpation than the-other groups, and BMP fusions showed significantly higher tensile strength and stiffer fusion. The histologic findings in the BMP group demonstrated membranous bone and endochondral bone formations between the transverse process and the fusion mass. In the other groups, continuous trabecular bone formation was observed in the area surrounding the transverse process, but gaps between grafted fragments and less mature bone formation were present in the intertransverse area.
Conclusions: Sintered bovine bone coated with Type I collagen and rhBMP-2 resulted in a higher fusion rate than the autograft and can be used as a carrier for rhBMP-2 in spinal fusion.