Page 125 - ENT IMPLANTS CATALOGUE IMPLANTS ORL

Conclusion: The NiTiBOND prosthesis allows early results to be obtained Objective: Analysis of 12-month midterm clinical and audiometric data
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similar to those with a manually crimped prosthesis fitted by experienced sur- of patients with otosclerosis who underwent stapedotomy using a newly
geons, thus reducing the learning curve in this critical step of the procedure. designed prosthesis made of nitinol, a shape memory alloy.
Objective: To analyze the 1-month results using the nitinol NiTiBOND Patients: Fifty-five ears of 50 consecutive patients who underwent stape-
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prosthesis in primary otosclerosis surgery and to compare the results with totomy between March 2010 and July 2011 were included. They met the
those obtained with fully fluoroplastic or fully titanium pistons. inclusion criteria of primary procedures, a clinical follow-up and absence
of nickel allergy.
Materials and Methods: Fifty consecutive cases operated on with the
NiTiBOND prosthesis (nitinol group) were compared with 50 cases oper- Intervention: Stapedotomy and insertion of a newly designed stapes prosthesis.
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ated on with a fully fluoroplastic piston (fluoroplastic group), and with 131
cases operated on with a fully titanium piston (first titanium group), and Main Outcome Measures: Preoperative and postoperative (3 and 12 mo)
also with 50 cases operated on with the same titanium piston just before air and bone conduction thresholds were recorded. Pure tone average and air
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using the NiTiBOND piston (last titanium group). Pure-tone and speech bone gap (difference of air and bone conduction thresholds) were calculated
audiometry was performed 1 month after surgery for the nitinol group. for 500, 1,000, 2,000, and 3,000 Hz. The occurrence of complications was
Comparison was made between the early hearing results of the four groups. assessed.
Results: The mean air-bone gap closure for the nitinol group was 16 ± 1.0 dB Results: Air conduction thresholds, pure tone average, and airbone gap
(mean ± SEM, n = 50); an air-bone gap of <15 dB and <10 dB was obtained improved significantly 3 and 12 months postoperatively. Bone conduction
in 100% and 84% of cases, respectively. These hearing results were similar threshold improved significantly at 2,000 Hz 3 months postoperatively and
to the last titanium group and significantly better than those observed in the at 1,000 and 2,000 Hz 12 months postoperatively. A PTA of less than 20 dB
fluoroplastic and first titanium groups. was achieved in 96% of ears. No sensorineural hearing loss or other pros-
thesis-related adverse effects were observed.
Promising Clinical Results of an Innovative Self-Crimping Conclusion: Postoperative hearing results are comparable to the results
Stapes Prosthesis in Otosclerosis Surgery obtained with other self-crimping prostheses. No complications or failures
related to the prosthesis occurred. A longer followup is necessary to prove
Schrötzlmair F., Suchan F., Kisser U., Hempel J.-M., Sroka R., long-term stability of hearing results and safety of the new prosthesis.
Müller J.
Published: Otology & Neurotology: December 2013 - Volume 34 - Issue Clinical Evaluation of the NiTiBOND Stapes Prosthesis,
9 - p 1571–1575. DOI: 10.1097/MAO.0b013e3182a5d12d an Optimized Shape Memory Alloy Design

Objectives: This clinical study was performed to retrospectively analyze Huber A. M., Schrepfer T., Eiber A.
the hearing improvement of patients with otosclerosis who underwent sta-
pesplasty with a novel nitinol prosthesis in comparison with the use of al- Published: Otology & Neurotology: February 2012 - Volume 33
ready established prostheses (titanium and clip prostheses) and to evaluate DOI: 10.1097/MAO.0b013e31823e28cb
the suitability of the nitinol prosthesis for ear surgeons with limited experi-
ence in otosclerosis surgery. Objective: To prospectively analyze short-term (3 mo) results in patients
with otosclerosis who underwent stapedotomy with the newly designed
Study Design: Retrospective data analysis. Setting: Tertiary referral center. NiTiBOND prosthesis and compare them with patients that underwent SMart
piston stapedotomy. We aimed to assess “noninferiority” for the new prosthesis.
Patients: Sixty patients who underwent otosclerosis surgery between July
1, 2010, and June 30, 2012, in the ENT department of the University of Study Design: Prospective controlled trial. Setting: Tertiary referral center.
Munich. Two patients were operated on both sides. For four patients, the Patients: Thirty-eight patients were included in the NiTiBOND group (41
stapesplasty was a revision surgery. ears), and 74 patients were included in the SMart Piston group (75 ears).
Intervention(s): Stapedotomy.
Interventions: Sixty-two procedures of otosclerosis surgery were per-
formed by 6 ear surgeons, one of whom with profound experience in sta- Main Outcome Measure(s): Pure-tone audiometry 3 months after surgery,
pesplasty. intraoperative prosthesis handling as assessed using a questionnaire, and
complications were analyzed.
Main Outcome Measures: 1) Postoperative air-bone gap, determined for
all surgeons together as well as itemized for the experienced and the nonex- Results: Pure-tone audiometry showed postoperative air-bone gap means
perienced stapes surgeons; 2) closure of the air-bone gap in 10 dB bins; and (standard deviation) of 8.1 (8.3) and 9.9 (5.4) dB; air-bone gap closure
3) change of high-tone bone-conduction level. 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.
Results: Pure-tone audiometry documented less postoperative air-bone gap Noninferiority was shown at all frequencies and in the pure-tone average.
and a higher percentage of air-bone gap closure when using the nitinol pros- The NiTiBOND prosthesis provides excellent intraoperative handling, and
thesis, especially in comparison with the clip prosthesis. Also, nonexperi- no adverse reactions were reported.
enced stapes surgeons received better audiometric results when using the
novel nitinol prosthesis. Conclusion: Preliminary short-term results suggest safety and reliability
for the new NiTiBOND stapes prosthesis.
Conclusions: Clinical evaluation suggests the novel nitinol prosthesis to be
a promising tool in otosclerosis surgery for experienced stapes surgeons as
well as for ear surgeons with limited experience in stapes surgery.
S TAPES PROS THESES
Mid-Term Results After a Newly Designed Nitinol
Stapes Prosthesis Use in 46 Patients Does the diameter of the stapes prosthesis really matter?
A prospective clinical study
Röösli C., Huber A. M.
Bernardeschi D., De Seta D., Canu G., Russo F.Y.,
Published: Otology & Neurotology 2013 Sep; 34(7) Ferrary E., Lahlou G., Sterkers O.
DOI: 10.1097/MAO.0b013e318299a973

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