Repair of an osseous facial critical-size defect using augmented fibrin sealant

Objective: Osseous defects of the head and neck are a common challenge for the otolaryngologist, To develop improved reconstructive options, osteocond uctive engineering experiments are being conducted. A nasal critical-size d efect (CSD) model has previously been described in which less than 7% bone healing is observed over 6 months. An implant containing fibrin sealant wit h and without osteoprogenitor cells is evaluated in this model. Study Desig n: Randomized controlled trial using a rodent model. Methods: A nasal CSD w as surgically created in 18 male retired breeder Sprague-Dawley rats. Six a nimals were not implanted with any material, six received fibrin sealant co nsisting of fibrin (25 mg/mL) and thrombin (1000 U/mL), and six were implan ted with fibrin sealant and rat calvarial osteoprogenitor cells (1.8 x 10(6 ) cells/mL), Thirty days later, the animals were examined at necropsy by pl animetry, histological analysis of new bone growth, and radiodensitometric analysis of bone thickness. Results: A thin layer of bone covered the defec t in all of the treated animals. A statistically significant increase in bo ne density (P <.05) between fibrin sealant plus osteoprogenitor cells and e ach of the other groups was shown using radiodensitometric analysis. Histol ogical analysis also confirmed this difference. Conclusion: Osteoprogenitor cells contained within fibrin sealant result in a greater augmentation of bone regeneration than controls or fibrin sealant alone.