Jack J Wazen1, Julie Daugherty2, Spencer Darley3, Benjamin Wycherly4. 1. Silverstein Institute, Ear Research Foundation, Sarasota, Florida. Electronic address: jwazen@earsinus.com. 2. Silverstein Institute, Ear Research Foundation, Sarasota, Florida. 3. Hearing & Balance Institute of Utah, Provo, Utah. 4. Connecticut Sinus Institute, Farmington, Connecticut.
Abstract
PURPOSE: The timing of loading of titanium craniofacial implants is dependent upon implant characteristics, host factors, and the bonding of titanium oxide and bone referred to as osseointegration. The purpose of this feasibility study seeks to determine the safety of early loading of the Baha BI-300 implant system (Cochlear Limited, Englewood, CO), which has been modified with novel surface texture and geometric design. SUBJECTS AND METHODS: This prospective study measures implant stability as determined by clinical evaluation and resonance frequency analysis at implantation and at 1, 3, 6, 12, 24 and 52weeks post-op in 20 patients who underwent single-stage implantation and exteriorization of the BI-300. The processor was loaded at 3weeks post-operatively. A modified Holger's classification system was used to evaluate skin reactions. RESULTS: There was a positive linear trend in mean implant stability scores from implantation to 52weeks. Only one subject (5%) had a mild local soft tissue Holger's grade 1 score at 24weeks. No implant loss or postoperative complications were encountered as a result of the 3-week loading. CONCLUSION: Three-week loading of the BI-300 implant did not result in any implant loss or failure of osseointegration. Earlier activation of the external processor with earlier hearing rehabilitation resulted in improved patient satisfaction. Further studies are needed to confirm these results for more universal adoption of early loading in adults.
PURPOSE: The timing of loading of titanium craniofacial implants is dependent upon implant characteristics, host factors, and the bonding of titanium oxide and bone referred to as osseointegration. The purpose of this feasibility study seeks to determine the safety of early loading of the Baha BI-300 implant system (Cochlear Limited, Englewood, CO), which has been modified with novel surface texture and geometric design. SUBJECTS AND METHODS: This prospective study measures implant stability as determined by clinical evaluation and resonance frequency analysis at implantation and at 1, 3, 6, 12, 24 and 52weeks post-op in 20 patients who underwent single-stage implantation and exteriorization of the BI-300. The processor was loaded at 3weeks post-operatively. A modified Holger's classification system was used to evaluate skin reactions. RESULTS: There was a positive linear trend in mean implant stability scores from implantation to 52weeks. Only one subject (5%) had a mild local soft tissue Holger's grade 1 score at 24weeks. No implant loss or postoperative complications were encountered as a result of the 3-week loading. CONCLUSION: Three-week loading of the BI-300 implant did not result in any implant loss or failure of osseointegration. Earlier activation of the external processor with earlier hearing rehabilitation resulted in improved patient satisfaction. Further studies are needed to confirm these results for more universal adoption of early loading in adults.
Authors: Jan Boucek; Jan Vokral; Libor Cerny; Martin Chovanec; Jiří Skrivan; Eduard Zverina; Jan Betka; Michal Zabrodsky Journal: Eur Arch Otorhinolaryngol Date: 2017-03-14 Impact factor: 2.503