Promising Clinical Results of an Innovative Self-Crimping Stapes Prosthesis in Otosclerosis Surgery

Abstract

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.

A systematic review of the effect of different crimping techniques in stapes surgery for otosclerosis

“…; date of last search was April 6, 2015). We included 22 articles after selection based on title and abstract and subsequent full text screening . No articles were excluded based on language, nor were any articles excluded because we could not retrieve the full‐text version.…”

“…In 19 studies, standardization of treatment was either not achieved or not adequately described. Primary and revision cases were combined in the analyses performed by Pudel and Briggs, van Rompaey et al, and Schrotzlmair et al It was not clear whether revision cases were included in the studies by Rajan et al (2007 and 2005) . In nine studies, a variety of fenestration techniques were used, including microinstruments, microdrills, and/or (different types of) lasers.…”

“…Various types of prostheses were included in the control groups of the studies performed by Fayad et al, Harris and Gong, Huber et al, and Kuo et al (2010) . Follow‐up duration was not standardized in seven studies . In an additional three studies, the mean follow‐up duration, standard deviation, or range were not adequately described.…”

“…From the study performed by Perkins et al, only procedures including a blood seal were included in our analyses; the treatment arm undergoing stapedotomy with vein graft interposition was excluded from our analyses because this procedure was only performed in the bucket prosthesis group. Three studies included more than two treatment arms . Six studies evaluated their study populations at more than one follow‐up moment .…”

Comparison of Audiometric and Functional Outcomes Between the Standard and Modified 360 Nitinol Shape Memory Stapes Prostheses

“…The invention of the nitinol prosthesis has been demonstrated in several publications to have excellent hearing outcomes with the added benefit of heat-activated self-crimping and thereby atraumatic application with interindividual reproducibility (5,16). Following studies demonstrating loosening or displacement of this prosthesis (4), the hook component of the original prosthesis was redesigned to confer a more secure circumferential fixation to the LPI.…”