A total of 260 cases (109 male, 151 female) with an age range of 15 to 77 years were included. Of these, 233 patients (90%) received the Teflon-platinum device, and 27 (10%) had the Nitinol device implanted. Generally, there was no difference in the types of otosclerotic conditions seen in the two groups, and most cases had disease around the anterior crus. In all cases, the small fenestra technique was used. A total of 91% of cases underwent stapedotomy with a laser. A drill was used in the other 9%.
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September 2008Overall, the Nitinol device performed better in closure of the air-bone gap. The researchers also looked at the postoperative rate of sensorineural hearing loss, which was defined as a loss of bone conduction of 10 dB. This was rare in our study but did occur in the Teflon-platinum group (0.9%). The largest loss we noted was 17 dB, Dr. Diaz said. There were no cases of sensorineural hearing loss in the Nitinol group.
The surgeons did encounter some issues with the placement of the Nitinol device. We saw some shortening of the device when we used the laser to crimp it. We had been using a 4.25-mm Telfon-platinum device, but did note that the Nitinol prosthesis at this length came out of the oval window on several occasions. Currently a 4.75-mm Nitinol piston is most often placed, Dr. Diaz said.
Occasionally, a prosthesis bent while it was being removed from its packaging. Dr. Diaz said the problem was corrected by using a laser to straighten the shaft.
Research Continues
Since their center has been using the Nitinol device, it has undergone some minor design changes. The first-generation Nitinol prosthesis had a nice circumferential crimp; it came packaged with the shepherd’s crook around a piston. The manufacturer has changed the packaging, which no longer includes the post, Dr. Diaz said.
Researchers are continuing to evaluate the device and its performance, but so far it is staying in the lead in terms of closing the postoperative air gap.
©2008 The Triological Society