Stability Testing of a Wide Bone-Anchored Device after Surgery without Skin Thinning

To longitudinally follow the osseointegration using Resonance Frequency Analysis (RFA) for different lengths of abutment on a new wide bone-anchored implant, introduced with the non-skin thinning surgical technique.

A single-center, prospective 1 year study following adults with bone-anchored hearing implants.

Implantation was performed and followed for a minimum of 1 year. All patients were operated on according to the tissue preserving technique. A 4.5 mm wide fixture (Oticon Medical) with varying abutments (9 to 12 mm) was used and RFA was tested 1 week, 7 weeks, 6 months, and 12 months later. Implant Stability Quotient (ISQ), was measured from 1 to 100. Stability was compared to a group of patients (N = 7) implanted with another brand (Cochlear BI400) of 4.5 mm fixtures.

All 10 adults concluded the study. None of the participants lost their implant during the test period indicating a good anchoring of abutments to the wide fixture tested. Stability testing was shown to vary depending on abutment length and time after surgery and with higher values for shorter abutments and increasing values over the first period of time. One patient changed the abutment from 12 to 9 mm and another from a 9 to a 12 during the year. No severe skin problems, numbness around the implant, or cosmetic problems arose.

After 1 year of follow-up, combination of a wide fixture implant and the non-skin thinning surgical technique indicates a safe procedure with good stability and no abutment losses.