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Comparative Study of Two Surgical Techniques for Soft Tissue Healing and Implant Stability of Cochlear BI300 Implants.

Aarhus University Hospital · 2012
ClinicalTrials.gov · Datasets · License: Public Domain · 2012
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artificialhearing-lossnaoperative
The study compares two different operative techniques for placement of the Cochlear Bi300 implant to be used for bone anchored hearing aid. The operative techniques to be compared are * Dermatome technique with soft tissue reduction * Linear incision with minimal or no soft tissue reduction The hypothesis is that the operative techniques are comparable with regard to implant stability, soft tissue healing and loss of sensibility around the implant. To evaluate the evolution of implant stability during the early healing period after implantation, which is the most critical period for osseointegrated implants, in particular when early loading protocols are used. To compare soft tissue healing around Baha implants placed according to the recommended surgical technique with skin transplant and Baha implants without performing skin reduction. To compare the loss of sensibility of the skin around the Baha implant (some loss of cutaneous sensibility nerves in the transplant procedure) between the two surgical procedures. While the study focuses on the early healing period (3 months), long-term safety data will also be collected after 6 months and 1-year. The study will also evaluate the change in health status produced by the surgical intervention.
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