Systematic Review of the Literature on Nitinol Prostheses in Surgery for Otosclerosis: Assessment of the Adequacy of Statistical Power

Otorhinolaryngology-Head and Neck Surgery, Antwerp University Hospital, University of Antwerp, Edegem, Belgium.
Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology (Impact Factor: 1.6). 04/2011; 32(3):357-66. DOI: 10.1097/MAO.0b013e31820e7874
Source: PubMed

ABSTRACT To perform a systematic review of observational studies reporting hearing outcome in primary stapes surgery where a heat-crimping prosthesis was used.
Medline, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, TRIP database, Clinical Trials Registry, ISI Web of Knowledge, and Web of Science. The search was performed on January 1, 2010, including articles published ahead of print. No language restrictions.
Inclusion criteria for qualitative synthesis were a population of otosclerosis patients, intervention being primary stapes surgery with a nickel titanium alloy (Nitinol) heat-crimping prosthesis, and hearing outcome. Inclusion criteria for quantitative analysis: application of audiometry guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Committee on Hearing and Equilibrium for evaluation of conductive hearing loss.
Strategy and reporting based on Cochrane, Quality of Reporting of Meta-analyses, and Meta-analysis of Observational Studies in Epidemiology statements. A bias assessment tool was developed according to Cochrane guidelines.
A quantitative synthesis was performed, but because of the heterogeneity in postoperative follow-up periods and outcome measures reported, we were not able to pool these data. A sample size analysis was performed to indicate the sample needed to demonstrate a statistically significant difference in hearing outcome between both interventions. Hearing outcome superiority of the Nitinol heat-crimping prosthesis over manually crimping prosthesis types was not demonstrated.
Superiority could probably not be demonstrated because of insufficient sample size. Research addressing technical improvements in stapes surgery should agree on a base sample size able to detect the smallest difference that is clinically important or accept the null hypothesis. With data gathered in the Common Otology Database as basis, a sample size of at least 413 patients is needed in both the intervention and the control group. Other clinical outcome measures also should be explored.

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    ABSTRACT: This clinical study was performed to retrospectively analyze the hearing improvement of patients with otosclerosis who underwent stapesplasty with a novel nitinol prosthesis in comparison with the use of already established prostheses (titanium and clip prostheses) and to evaluate the suitability of the nitinol prosthesis for ear surgeons with limited experience in otosclerosis surgery. Retrospective data analysis. Tertiary referral center. Sixty patients who underwent otosclerosis surgery between July 1, 2010, and June 30, 2012, in the ENT department of the University of Munich. Two patients were operated on both sides. For four patients, the stapesplasty was a revision surgery. Sixty-two procedures of otosclerosis surgery were performed by 6 ear surgeons, one of whom with profound experience in stapesplasty. 1) Postoperative air-bone gap, determined for all surgeons together as well as itemized for the experienced and the nonexperienced stapes surgeons; 2) closure of the air-bone gap in 10 dB bins; and 3) change of high-tone bone-conduction level. Pure-tone audiometry documented less postoperative air-bone gap and a higher percentage of air-bone gap closure when using the nitinol prosthesis, especially in comparison with the clip prosthesis. Also, nonexperienced stapes surgeons received better audiometric results when using the novel nitinol prosthesis. 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.
    Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 12/2013; 34(9):1571-1575. DOI:10.1097/MAO.0b013e3182a5d12d · 1.60 Impact Factor
  • The Laryngoscope 09/2014; 124(9). DOI:10.1002/lary.24627 · 2.03 Impact Factor
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    ABSTRACT: Compared to traditional stapes prostheses, self-crimping prostheses have been shown to result in similar, if not better, closure of the air bone gap in patients undergoing stapedotomy for otosclerosis. To achieve self-crimping, nitinol, a shape memory alloy, has been used for several years but concerns have been raised regarding possible damage to the incus and its muco-periosteum. We investigate these concerns with regard to the newer NiTiBOND stapes prosthesis in an observational multi-centre study.In a multicentre, prospective observational study, 76 patients undergoing stapedotomy with the NiTiBond prosthesis across 4 centres were compared to 75 -retrospectively selected control SMart patients. Complications, intra-operative user-friendliness and audiological results at 3 months were documented.Audiological improvement and the rate of complications were similar in both groups. Non inferiority was shown at all frequencies and in the pure-tone average. The NiTiBOND prosthesis was described as very user-friendly.By eliminating manual crimping, stapedotomy using the NiTiBOND prosthesis can be facilitated and standardized. Furthermore, intraoperative handling characteristics of the prosthesis are very good which may further reduce operative risk. Importantly, we show that these benefits are not to the detriment of audiological outcome. Larger and longer-term studies are required to further evaluate results.
    Laryngo-Rhino-Otologie 10/2013; DOI:10.1055/s-0033-1354378 · 0.99 Impact Factor


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May 28, 2014