The "C-Bending-spring-tympanoplasty" for Reconstruction of Anterior Tympanic Membrane Defects: A Prospective Randomized Clinical Trial.

INTRODUCTION:Anterior tympanic membrane (TM) defects present a surgical challenge due to the lack of support for the graft, resulting in reduced success rates. Established anchoring tympanoplasty (EAT) techniques usually aim to anchor the graft to the anterior rim of the TM. The "cartilaginous bending spring tympanoplasty" (CBST) secures the graft to the TM by supporting it with a U-shaped bending spring cartilage placed underneath in the middle ear. Initial experimental studies have already shown the feasibility of CBST without impeding sound transmission. This prospective clinical study evaluates the outcome of CBST compared to EAT in terms of closure of TM defects and hearing outcome. MATERIALS AND METHODS:This randomized controlled study was conducted at a tertiary referral center from March 22, 2018 to September 17, 2020. Patients were randomized to surgeon and reconstruction technique (EAT vs CBST). Inclusion criteria were chronic otitis media with TM defects that involved at least the anterior part of the TM, subtotal defects, and an intact ossicular chain. Primary objectives were the successful reconstruction of the TM and the hearing outcome. RESULTS:Fifty-five patients (55 ears; CBST n = 26, right ears = 13; EAT n = 28, right ears = 8) with a mean age of 46.1 ± 15.0 years and a mean follow-up of 140.4 ± 86.7 days were included. The TM was successfully reconstructed in 95% of cases in both groups. Hearing improvement was comparable for both groups (improvement of air-bone gap: EAT: 3.0 ± 9.3 dB; CBST: 5.5 ± 6.2 dB; P = .244; Cohen's d = 0.318). CONCLUSION:CBST allows for comparably high success rates of reconstruction of anterior TM defects and the hearing outcome. Accordingly, the U-spring bending cartilage supporting the graft does not adversely affect hearing outcome. Thus, CBST can be considered a useful technique to close anterior defects of the TM effectively.