Matthew Yung1, Philip Smith. 1. Department of Otolaryngology, The Ipswich Hospital NHS Trust, Suffolk, UK. matthewyung@btconnect.com
Abstract
OBJECTIVE: The study compares the medium-term outcome of ossiculoplasty using titanium and nontitanium prostheses. STUDY DESIGN: Randomized controlled, prospective clinical trial. SETTING:District general hospital. PATIENTS: Patients with chronic otitis media with partial and total ossicular reconstructions were included. Trauma and congenital malformation cases were excluded. INTERVENTION(S): Partial and total ossicular reconstructions using either titanium (Ti) or hydroxyapatite (HA) prostheses. Cartilage plate was used to cover the Ti head plate but not the HA head plate. MAIN OUTCOME MEASURE(S): The principal outcome was hearing gain and postoperative air-bone gaps. The secondary outcome was extrusion of the prosthesis. RESULTS: The mean hearing gain in the HA partial ossicular replacement prosthesis (PORP) and the Ti PORP cohorts were 14.30 and 15.10 dB, respectively. The mean hearing gain in the HA total ossicular replacement prosthesis (TORP) and Ti TORP cohorts were 13.52 and 13.48 dB, respectively. There was no significant difference between HA and Ti for both PORPs and TORPs. There also was no significant difference in the extrusion rate between both prostheses. CONCLUSION: The lack of statistical difference in the clinical outcome of the 2 prostheses may be due to the limitation of randomized controlled trial with the small sample size and limited statistical power in the comparison of surgical techniques.
RCT Entities:
OBJECTIVE: The study compares the medium-term outcome of ossiculoplasty using titanium and nontitanium prostheses. STUDY DESIGN: Randomized controlled, prospective clinical trial. SETTING: District general hospital. PATIENTS: Patients with chronic otitis media with partial and total ossicular reconstructions were included. Trauma and congenital malformation cases were excluded. INTERVENTION(S): Partial and total ossicular reconstructions using either titanium (Ti) or hydroxyapatite (HA) prostheses. Cartilage plate was used to cover the Ti head plate but not the HA head plate. MAIN OUTCOME MEASURE(S): The principal outcome was hearing gain and postoperative air-bone gaps. The secondary outcome was extrusion of the prosthesis. RESULTS: The mean hearing gain in the HA partial ossicular replacement prosthesis (PORP) and the Ti PORP cohorts were 14.30 and 15.10 dB, respectively. The mean hearing gain in the HA total ossicular replacement prosthesis (TORP) and Ti TORP cohorts were 13.52 and 13.48 dB, respectively. There was no significant difference between HA and Ti for both PORPs and TORPs. There also was no significant difference in the extrusion rate between both prostheses. CONCLUSION: The lack of statistical difference in the clinical outcome of the 2 prostheses may be due to the limitation of randomized controlled trial with the small sample size and limited statistical power in the comparison of surgical techniques.
Authors: G Lahlou; G Sonji; D De Seta; I Mosnier; F Y Russo; O Sterkers; D Bernardeschi Journal: Acta Otorhinolaryngol Ital Date: 2018-08 Impact factor: 2.124