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Incus Autograft Partial Ossicular Reconstruction Prosthesis vs. Titanium Angular Clip Prosthesis in Patients with Incudostapedial Joint Erosion Caused by Chronic Otitis Media; A Randomized Clinical Trial

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Abstract

Chronic otitis media (COM) is a common disease that can cause damage to the middle ear ossicles and thus lead to conductive hearing loss. The purpose of this study was to compare two methods of incus partial ossicular reconstruction prosthesis (PORP) and reconstruction with titanium angular clip prosthesis in patients with incudostapedial joint erosion. In this interventional randomized clinical trial carried out in a tertiary referral hospital, patients with chronic otitis media and incudostapedial joint erosion who were candidates for surgery, were randomly allocated into two groups of incus PORP surgery and reconstruction with a titanium angular clip prosthesis. Audiometry was performed for the patients prior to and six months after surgery. Pre- and post-operative air–bone gap (ABG) and bone conduction (BC) thresholds were calculated and means were compared by analysis of variances (ANOVA). A P value of <0.05 was considered statistically significant. The study consisted of 24 and 14 subjects in the incus PORP and angular clip groups, respectively. There was no statistically significant difference between the mean pre- and post-operative ABG, BC thresholds and ABG reduction in the compared groups. Considering issues such as high cost and inaccessibility of titanium angular clips in all centers, incus PORP may be a more acceptable method.

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Funding

This study was funded by Otorhinolaryngology Research Center of Tehran University of Medical Sciences.

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Authors and Affiliations

  1. Otorhinolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran

    Hamed Emami & Mehrdad Jafari

  2. Private Practice, Hamedan, Iran

    Fatemeh Shojasefat

  3. Internal Medicine Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran

    Atieh Moghtadaie

  4. Sina Hospital, Department of Surgery, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran

    Seyed Amir Miratashi Yazdi

  5. Otolaryngology Department, Vasliasr Hospital, Imam Khomeini Hospital Complex, Baqerkhan St, Tehran, Iran

    Mehrdad Jafari

Authors
  1. Hamed Emami
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  2. Fatemeh Shojasefat
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  3. Atieh Moghtadaie
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  4. Seyed Amir Miratashi Yazdi
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  5. Mehrdad Jafari
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Corresponding author

Correspondence to Mehrdad Jafari.

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Conflict of Interest

The authors declare that they have no conflict of interest.

Ethics Approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.IKHC.REC.1395.1673).

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Informed consent was obtained from all individual participants included in the study. Patients signed informed consent regarding publishing their data.

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Emami, H., Shojasefat, F., Moghtadaie, A. et al. Incus Autograft Partial Ossicular Reconstruction Prosthesis vs. Titanium Angular Clip Prosthesis in Patients with Incudostapedial Joint Erosion Caused by Chronic Otitis Media; A Randomized Clinical Trial. Indian J Otolaryngol Head Neck Surg 74, 85–89 (2022). https://doi.org/10.1007/s12070-021-02605-w

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  • DOI: https://doi.org/10.1007/s12070-021-02605-w

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