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 Table of Contents  
ORIGINAL ARTICLE
Year : 2016  |  Volume : 22  |  Issue : 2  |  Page : 119-122

A comparison of autograft incus and titanium prostheses in primary ossiculoplasty in modified radical mastoidectomy


Department of Otorhinolaryngology, PGIMER Dr. Ram Manohar Lohia Hospital, New Delhi, India

Date of Web Publication11-May-2016

Correspondence Address:
Ankur Gupta
Department of Otorhinolaryngology, 2nd Floor, OPD Block PGIMER Dr. Ram Manohar Lohia Hospital, Baba Kharag Singh Marg, New Delhi - 110 001
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0971-7749.182288

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  Abstract 

Background: Numerous graft materials are available for ossicular reconstruction yet, no single option is considered ideal. This study aims to analyze and compare the outcome of primary ossiculoplasty in terms of hearing gain using autograft incus and titanium (Ti) prostheses in patients with active squamosal chronic otitis media (COM) undergoing modified radical mastoidectomy (MRM). Study Design: Randomized study. Materials and Methods: Sixty patients with active squamosal COM with ossicular chain erosion undergoing MRM were divided into two equal groups. First group underwent ossiculoplasty with autograft incus and the second group received Ti prostheses. Follow-up was done over a period of 6 months and hearing thresholds were evaluated postoperatively at 3rd and 6th month at the four frequency average of 0.5/1/2/4 KHz. Results: There was no significant difference in air conduction (AC) gain when the inter-group comparison is made (P > 0.05 at 3rd and 6th month), however, intra-group AC gain was significant in both groups, at the end of the 3rd month and 6th month (P < 0.05). Conclusion: Autograft incus and Ti prostheses both give a comparable hearing gain in ossicular reconstruction. Ti prostheses are a good alternative in longstanding cases of active squamous COM without any available ossicular autograft for hearing reconstruction.

Keywords: Active squamosal disease, Chronic otitis media, Incus, Ossiular autografts, Titanium


How to cite this article:
Gupta A, Kumar A, Sen K, Tuli IP. A comparison of autograft incus and titanium prostheses in primary ossiculoplasty in modified radical mastoidectomy. Indian J Otol 2016;22:119-22

How to cite this URL:
Gupta A, Kumar A, Sen K, Tuli IP. A comparison of autograft incus and titanium prostheses in primary ossiculoplasty in modified radical mastoidectomy. Indian J Otol [serial online] 2016 [cited 2019 Nov 18];22:119-22. Available from: http://www.indianjotol.org/text.asp?2016/22/2/119/182288


  Introduction Top


Interposition of refashioned incus body as a bridge between the stapes and the malleus was the original ossicular reconstruction surgery. Titanium (Ti) ossicular reconstruction prostheses have been used clinically since 1990. Various grafts (autografts/allografts) have been used for ossicular reconstructions such as cortical bone, refashioned ossicles, tragal or septal cartilage, and also total or partial ossicular replacement prostheses (TORP or PORP).[1] An ideal graft should be biocompatible, have suitable rigidity, long-term durability, and minimal technical challenge for placement. In this study, we aimed to compare the postoperative hearing outcome in patients undergoing modified radical mastoidectomy (MRM) and primary ossiculoplasty with autograft incus and Ti prostheses, respectively.


  Materials and Methods Top


This study was conducted at PGIMER Dr. RML Hospital, a tertiary care academic hospital, on sixty patients of chronic otitis media (COM). The study period was from October 2012 to March 2014. The inclusion criteria for the patients were those with (i) active squamosal COM with ossicular erosion undergoing MRM; (ii) age between 15 and 50 years, (iii) patients who consented for the surgery. Patients having a conductive hearing loss due to other causes, patients having mixed hearing loss and patients undergoing revision surgery were excluded from the study. All patients were assessed with detailed history, systemic examination, comprehensive ENT examination, pure tone audiometry, and otomicroscopy. Radiological assessment of temporal bone was done and those patients with evidence of ossicular erosion were subjected to ossiculoplasty with autologous incus (Group A) or Ti prostheses (Group B).

Ethical approval

Ethical clearance was obtained from the Institutional Ethical Committee.

Surgical technique

The patients were divided into two equal groups randomly using a simple random number table. First group (Group A) underwent reconstruction with refashioned autologous incus and the second group (Group B) received Ti prostheses. TTP-VARIO Ti prostheses from Kurz were used for reconstruction. All patients underwent MRM under general anesthesia via the postaural route. In Group A, the incus with necrosed lenticular process was detached from the incudomalleal joint and taken out. A primary ossiculoplasty was performed with a disease-free sculptured incus to make a neck of malleus to the head of stapes assembly. In patients where stapes superstructure was absent, the incus graft was placed between the handle of malleus and stapes footplate. In Group B, Ti prostheses, PORP or TORP were used determined by the presence or absence of stapes head. [Figure 1] shows a Ti TORP placed on stapes footplate.
Figure 1: Titanium total ossicular replacement prostheses placed over stapes footplate

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Conchal cartilage was placed over Ti prostheses to prevent extrusion, followed by temporalis fascia graft placement and adequate meatoplasty. The surgical cavity was packed with bismuth iodoform paraffinized paste, and the wound was sutured. All patients were put on antibiotics, analgesics and antihistamines in the postoperative period.

Follow-up was done over 6 months. Hearing thresholds were evaluated postoperatively at 3rd and 6th month at the four frequency average of 0.5/1/2/4 KHz in accordance with the American Academy of Otolaryngology-Head and Neck Surgery standards except for threshold at 3 KHz, which was substituted in all cases with thresholds at 4 KHz. Hearing outcome was evaluated in terms of the air-bone gap (ABG) closure and air conduction (AC) gain.

Statistical analysis

We analyzed our data using the statistical package for the social science system version SPSS 17.0 (IBM Corp. Released 2011. IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.). The comparison of normally distributed continuous variables between the groups was performed using Student's t-test and within the groups using Paired t-test. Nominal categorical data between the groups were compared using Chi-square test or Fisher's exact test as appropriate. P < 0.05 was considered statistically significant.

Limitations

In our study, patients were followed up over a period of 6 months, however, a much longer follow-up period is required to assess the long-term outcomes of ossiculoplasty.


  Results Top


The profile of all the sixty cases analyzed is shown in [Table 1].
Table 1: Basic characteristics of the two groups (n=60)

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In Groups A and B mean age of patients was 26.83 and 29.83 years, respectively. In Group A, 63.3% were males as compared to 53.3% in Group B and 36.7% were females as compared to 46.7%. Preoperative mean hearing loss was 30.67 dB (standard deviation [SD] = 8.48) in Group A as compared to 31.2 dB (SD = 10.64) in Group B. These intergroup variables were not significant.

Intra-operatively, cholesteatoma (Ch) was present in thirty cases, granulations (Gr) in 8 cases and both Ch and Gr in 15 cases. Seven patients had on disease as assessed during surgery. Disease was distributed equally in the two groups as shown in [Table 2].
Table 2: Comparison of intraoperative disease pattern in groups

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[Table 3] and [Table 4] compare the postoperative hearing outcome of ossiculoplasty with autologous incus and Ti prostheses at 3rd and 6th month, respectively.
Table 3: Comparison of postoperative hearing results in groups at 3rd month

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Table 4: Comparison of postoperative hearing results in groups at 6th month

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In Group A, at 3 months, 83.3% patients (n = 25) had hearing improvement with 73.3% experiencing a gain between 5 and 20 dB. Three patients had excellent results with two patients having a gain of 25 dB and one with a gain of 30 dB. No improvement noted in the five patients. No extrusion was noted. However, in Group B, 60% patients (n = 18) had hearing gain with five patients having AC gain of >20 dB. Nine patients had no hearing improvement with three patients developing extrusion of prostheses.

In Group A, at 6 months, 80% patients had AC gain. Majority (n = 21) patients had gain between 5 and 20 dB. One patient had an AC gain of 30 dB, and two patients had a gain of 25 dB. Six patients showed no improvement. In Group B, 60% patients (n = 18) had hearing gain where one patient had AC gain of 35 dB, three patients had gain of 30 dB, five patients had gain of 25 dB, and 9 patients had gain between 5 and 20 dB. Nine patients had no hearing improvement, and three patients showed extrusion of prostheses. [Table 5],[Table 6],[Table 7] show intra-group pre- and post-operative ABG comparison. In our study, at 6 months, mean AC gain was 10 dB and mean ABG closure was 18.17 dB (13.68 S.D.) in Group A whereas in Ti group mean AC gain was 10.7 dB and mean ABG closure was 20.93 (12.71 SD). [Table 8] shows the intergroup comparison of ABG closure and mean AC gain at 6 months.
Table 5: Overall comparison of pre- and post-operative ABG at 6th month

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Table 6: Intra-group comparison of pre- and post-operative air-bone gap at 6th month

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Table 7: Intra-group comparison of pre- and post-operative air-bone gap at 6 months

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Table 8: Inter-group comparison of mean air conduction gain and air-bone gap closure at 6 months

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  Discussion Top


The numerous techniques and middle ear prostheses available to otologic surgeon lend credence to the idea that ossicular chain reconstruction techniques remain to be perfected.[2] For more than five decades, otologists have been in search for perfect prostheses. Three general classes of prostheses are used today: autograft, homograft, and allograft.[3] Autograft prostheses include ossicles (incus, malleus), cartilage, and cortical bone. The autograft prostheses have a very low extrusion rate, no risk of transmitting disease, biocompatibility, and no necessity for reconstitution. Displacement, complete absorption, small remnant size, and possibility of harboring microscopic disease have been cited as potential disadvantages to their use.[4] Various new alloplastic prostheses made up of plastic, ceramic, Teflon, wire prosthesis such as stainless steel, tantalum, platinum, hydroxyapatite, and Ti are in use, but none had fit in the criteria of an ideal graft. Extrusion of the prostheses is reported as high as 39% and can be significantly reduced by placing cartilage or bone between the tympanic membrane and the prostheses.[5]

In this study, Ti prostheses (TORP and PORP) have been used as it is an excellent material for ossicular reconstruction because of its high biocompatibility, osseointegration, biostability, and low ferromagnetism. It is lightweight and rigid, making it a good sound conductor.[6] The hearing assessment postoperatively was done at 3rd and 6th month. We found no significant difference in hearing gain between two groups at 6 months however the complication rate was less in the autograft group. Incus transposition is well tolerated as it is more physiological and biocompatible having lower extrusion rates. This technique requires time and skill to ensure appropriate sculpting to minimize ankylosis of the fallopian canal, scutum, and posterior canal wall.[4]

Three patients who had reconstruction with TORP developed severe sensorineural hearing loss at the end of 3 months, possibly due to pressure necrosis of stapes footplate caused by the weight of prosthesis.

In a large multicentric series on 528 patients, Begall and Zimmermann reported an improvement of the ABG of 15 dB at the 6-month follow-up.[7] Another series on 102 patients, reported an improvement of the ABG to <20 dB in 70% with PORP and <30 dB with TORP.[8] We achieved a similar postoperative AB gap of 20.93 dB in Ti group at 6 months. Multiple factors such as tension of the assembly, round window protection, the angle between Tm and prostheses and middle ear space impact successful reconstruction of the middle ear's sound conduction mechanism.[9] Excessive tension dampens sound energy and worsens hearing results.[10] An excessively loose coupling is prone to displacement and introduces unwanted resonance that can distort the primary signal.[11] The air space around the ossicular chain should be more than 0.3 ml.[12] These factors were kept in mind when performing ossiculoplasty during this study. Studies by Meister et al. and Kelly et al. suggest that mass is the most important variable and, therefore, recommend that prostheses should be as light as possible to optimize transmission of frequencies above 1000 Hz.[13],[14] The success of ossiculoplasty therefore depends upon appropriate prostheses design, and the surgeon's ability to achieve a tight, permanent coupling between the Tm and stapes. Very few randomized clinical trials from the Indian subcontinent are available in literature comparing hearing outcome of ossiculoplasty with autologous incus and Ti prostheses and, therefore, there is scope for more similar studies with longer follow-up in near future.


  Conclusion Top


Autograft incus and Ti prostheses both gave a comparable hearing gain in primary ossiculoplasty in MRM however both grafts do have significant improvement in hearing outcome. It is worthwhile to conclude that many more clinical trials with the larger study group and a longer follow-up are required to establish the above results more firmly but definitely Ti prostheses can be a good option in patients undergoing MRM where autografts are not available for ossicular reconstruction.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Frootko NJ. Reconstruction of middle ear. In: Scott Brown's Otolaryngology. 6th ed. Ch. 11. United Kingdom: Butterworth-Heinemann; 1997. p. 8-24.  Back to cited text no. 1
    
2.
Telian S, Schmalbach C. Chronic otitis media. In: Ballanger's. Otorhinolaryngology Head and Neck Surgery. 16th ed. Hamilton, Ontario: BC Decker Inc.; 1996. p. 280-2.  Back to cited text no. 2
    
3.
O'Reilly RC, Cass SP, Hirsch BE, Kamerer DB, Bernat RA, Poznanovic SP. Ossiculoplasty using incus interposition: Hearing results and analysis of the middle ear risk index. Otol Neurotol 2005;26:853-8.  Back to cited text no. 3
    
4.
Kartush JM. Ossicular chain reconstruction. Capitulum to malleus. Otolaryngol Clin North Am 1994;27:689-715.  Back to cited text no. 4
    
5.
Smyth GD. Five-year report on partial ossicular replacement prostheses and total ossicular replacement prostheses. Otolaryngol Head Neck Surg 1982;90 (3 Pt 1):343-6.  Back to cited text no. 5
    
6.
Martin AD, Harner SG. Ossicular reconstruction with titanium prosthesis. Laryngoscope 2004;114:61-4.  Back to cited text no. 6
    
7.
Begall K, Zimmermann H. Reconstruction of the ossicular chain with titanium implants. Results of a multicenter study. Laryngorhinootologie 2000;79:139-45.  Back to cited text no. 7
    
8.
Gardner EK, Jackson CG, Kaylie DM. Results with titanium ossicular reconstruction prostheses. Laryngoscope 2004;114:65-70.  Back to cited text no. 8
    
9.
Athanasiadis-Sismanis A, Poe DS. Ossicular chain reconstruction. In: Gulya AJ, editor. Surgery of the Ear. 6th ed. New Delhi: CBS Publishers; 2012. p. 491.  Back to cited text no. 9
    
10.
Goldenberg RA. Hydroxylapatite ossicular replacement prostheses: Results in 157 consecutive cases. Laryngoscope 1992;102:1091-6.  Back to cited text no. 10
    
11.
Goldenberg RA, Emmet JR. Current use of implants in middle ear surgery. Otol Neurotol 2001;22:145-52.  Back to cited text no. 11
    
12.
Athanasiadis-Sismanis A, Poe DS. Ossicular chain reconstruction. In: Gulya AJ, editor. Surgery of the Ear. 6th ed. New Delhi: CBS Publishers; 2012. p. 492.  Back to cited text no. 12
    
13.
Meister H, Walger M, Mickenhagen A, von Wedel H, Stennert E. Standardized measurements of the sound transmission of middle ear implants using a mechanical middle ear model. Eur Arch Otorhinolaryngol 1999;256:122-7.  Back to cited text no. 13
    
14.
Kelly DJ, Prendergast PJ, Blayney AW. The effect of prosthesis design on vibration of the reconstructed ossicular chain: A comparative finite element analysis of four prostheses. Otol Neurotol 2003;24:11-9.  Back to cited text no. 14
    


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]



 

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