Clinical evaluation of the NiTiBOND stapes prosthesis, an optimized shape memory alloy design.

OBJECTIVE

To prospectively analyze short-term (3 mo) results in patients with otosclerosis who underwent stapedotomy with the newly designed NiTiBOND prosthesis and compare them with patients that underwent SMart piston stapedotomy. We aimed to assess "noninferiority" for the new prosthesis.

STUDY

DESIGN

Prospective controlled trial.

SETTING

Tertiary referral center.

PATIENTS: Thirty-eight patients were included in the NiTiBOND group (41 ears), and 74 patients were included in the SMart Piston group (75 ears).

INTERVENTION(S): Stapedotomy.

MAIN OUTCOME MEASURE(S): Pure-tone audiometry 3 months after surgery, intraoperative prosthesis handling as assessed using a questionnaire, and complications were analyzed.

RESULTS

Pure-tone audiometry showed postoperative air-bone gap means (standard deviation) of 8.1 (8.3) and 9.9 (5.4) dB; air-bone gap closure within 10 dB was achieved in 71% and 72% and within 20 dB in 93% and 96% for the NiTiBOND and the SMart piston prosthesis, respectively. Noninferiority was shown at all frequencies and in the pure-tone average. The NiTiBOND prosthesis provides excellent intraoperative handling, and no adverse reactions were reported.

CONCLUSION

Preliminary short-term results suggest safety and reliability for the new NiTiBOND stapes prosthesis.