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概要
A Retrospective Clinical Comparison of Two Allogeneic Bone Matrices Containing Viable Osteogenic Cells in Patients Undergoing Foot and/or Ankle Arthrodesis
Jeff D Loveland, Erik I Waldorff, David Y He and Brent L Atkinson
Background: Cellular bone allograft possesses the osteogenic, osteoinductive, and osteoconductive elements essential for bone healing. The purpose of this study was to compare the fusion rates of two cellular bone allografts that differ in the minimum number of inherent osteogenic cells for foot and/or ankle arthrodeses.
Methods: A retrospective comparative evaluation of patients treated with Trinity Evolution® and Trinity ELITE® was performed. At baseline and at 3, 6 and 12 months, standard radiographs were taken to evaluate the fusion status. The study population consisted of 75 subjects and 141 total arthrodeses.
Results: At 3, 6 and 12 months, the fusion rate was 57.3, 79.4 and 93.3% of subjects and 58.9, 83.9 and 95.7% of joints, respectively, for the combined Trinity Evolution and Trinity ELITE group. There were no significant differences in fusion rates observed between these grafts at any timepoint. Certain subjects with risk factors (e.g. diabetic, obese, elderly) had fusion rates comparable to normal patients. Fusion rates using these grafts were not adversely affected by several risk factors.
Conclusions: Both Trinity Evolution and Trinity Elite effectively achieve fusion in patients with compromised bone healing and provides safety and effectiveness in foot and/or ankle arthrodeses. These cellular bone allografts appear to have the minimum threshold number of cells that are required to achieve a successful fusion.
Trial registration: Not required for retrospective studies.