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ISSN: Print -2349-0977, Online - 2349-4387


 
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ORIGINAL CONTRIBUTION: PROSTHETICS IN OTORHINOLARYNGOLOGY
Year : 2015  |  Volume : 2  |  Issue : 3  |  Page : 111-115

Comparative evaluation of early results with ossicular reconstruction employing titanium and hydroxyapatite prostheses


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

Date of Web Publication2-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: 10.4103/2349-0977.181509

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  Abstract 

Background: Synthetic graft materials are needed for ossicular reconstruction in chronic otitis media (COM) when autografts are inadequate. This study aims to analyze and compare the outcome of ossiculoplasty in terms of hearing gain using titanium (Ti) and hydroxyapatite (HA) prostheses in patients with COM. Study Design: Quasi-randomized study. Materials and Methods: Seventy patients of COM with air-bone gap (ABG) >40 dB were divided into two equal groups. The first group was reconstructed with Ti and the second group with HA prostheses. Hearing thresholds were evaluated postoperatively at 3rd and 12th month at the four frequency averages of 0.5/1/2/4 kHz. Results: There was no significant difference in ABG closure when intergroup comparison is made (P > 0.05 at 3rd and 12th months); however, intragroup ABG closure was significant in both groups, at the end of the 3rd month and 12th month (P < 0.05). Conclusion: Both prostheses give comparable hearing gain in ossicular reconstruction. These prostheses are a good alternative in longstanding cases of COM without any available ossicular autograft for hearing reconstruction.

Keywords: Active squamosal disease, autografts, chronic otitis media, hydroxyapatite, titanium


How to cite this article:
Gupta A, Kumar A, Tuli IP, Soni P. Comparative evaluation of early results with ossicular reconstruction employing titanium and hydroxyapatite prostheses. Astrocyte 2015;2:111-5

How to cite this URL:
Gupta A, Kumar A, Tuli IP, Soni P. Comparative evaluation of early results with ossicular reconstruction employing titanium and hydroxyapatite prostheses. Astrocyte [serial online] 2015 [cited 2019 Aug 17];2:111-5. Available from: http://www.astrocyte.in/text.asp?2015/2/3/111/181509


  Introduction Top


Hydroxyapatite (HA) is an excellent bioactive prosthetic material, in use since the 1970s, that has osseointegrative properties when used as a bone implant.[1] Satisfactory long-term results have been reported with HA.[2],[3] The most common form of HA used in reconstruction is the dense form. Titanium (Ti) on the other hand has greater versatility than HA. Ti middle ear prostheses were introduced by Stupp in 1993.[4] Ti was also established as an excellent biocompatible material in the 1970s.[5] The present study compares the results of HA and Ti prostheses in reconstruction of the middle ear ossicular chain in patients with chronic otitis media (COM).


  Materials and Methods Top


The study was conducted at Dr. Ram Manohar Lohia Hospital, New Delhi, on 70 patients of COM with air-bone gap (ABG) more than 40 dB on audiometric assessment, from October 2010 to March 2012.

Patients with conductive hearing loss due to other causes, mixed hearing loss, and those undergoing revision surgeries were excluded from the study. The patients were quasi-randomized in two equal groups. Although the method of randomization seemed to be apparently biased but on comparison, it was found that the two groups were comparable with respect to demographic characteristics. All patients were assessed with detailed history, ENT examination, and audiometry at four frequencies: - 500, 1000, 2000, and 4000 Hz. High-resolution computed tomography scan was done in patients with active squamosal disease to assess the extent of disease and status of  Fallopian canal More Details. All patients underwent either canal wall up (CWU) or canal wall down (CWD) mastoidectomy. Patients were operated under general anesthesia via postaural route. First group (Group A) was reconstructed with Ti prostheses and second group (Group B) with HA prostheses.

The TTP VARIO prostheses of ASTM F67 Medical Grade developed by Heinz Kurz Gmbh Medizintechnik, Germany, and 100% HA prostheses developed by Audio TechnologiesR @ Italy, were used during the study. The prostheses were length adjustable in 0.25 mm increments. The TTPT M-VARIO Instrument set was used for secure fastening of the head plate to the shaft. The prostheses head was covered with a conchal cartilage in all cases. [Figure 1] and [Figure 2] shows Ti and HA TORP placed over stapes foot plate, respectively. All patients were put on antibiotics, analgesics, and antihistamines in the postoperative period.
Figure 1: Titanium total ossicular replacement prosthesis in place and being covered with conchal cartilage.

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Figure 2: Hydroxyapatite total ossicular replacement prosthesis in place.

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Postoperatively pure tone audiometric evaluation was performed at 3rd month and 1 year to assess hearing outcome at the four frequency average of 0.5/1/2/4 kHz. We recorded results as preoperative ABG, postoperative ABG, and ABG closure. A postoperative ABG of 20 dB or less was taken to represent successful hearing.

Statistical analysis

The SPSS v15.0 was used to analyze the data. For determining statistical significance, 95% confidence interval was taken. The paired t-test was applied to compare the difference between the means of ABG pre and post-operatively. The qualitative data was analyzed using the chi square test and Fischer exact test.


  Results Top


[Table 1] shows the age distribution in groups. Age of the patients ranged from 9-39 years with majority in between 21-30 years (42.86%, n = 30). No statistical difference was observed in the means of the age in both groups (P = 0.520). Distribution of sexes was also not significance (P = 0.467) as shown in [Table 1] and [Table 2].
Table 1: Age Distribution in Groups

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Table 2: Gender Distribution in Groups

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The Mean ABG in the Ti group was 35 dB, while in the HA group it was 36.36 dB (P = 0.358). Pre-operative Mean and Frequency specific ABG values are shown in [Table 3]. Patients had either CWU or CWD mastoidectomy with majority (n = 43, 61.4%) underwent CWD procedure. This difference was not significant thus not affecting the result [Table 3] and [Table 4].
Table 3: Preoperative Mean - and Frequency-Specific Air-Bone Gap Values

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Table 4: Comparison of Patient Undergoing Mastoidectomies in Groups

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Peroperatively, majority had (n = 27; 38.6%) an ossicular status belonging to the Austin Kartush type A. No difference was found in the distribution of the patients in groups in terms of Ossicular Status (P = 0.706) as shown in [Table 5]. Overall, cholesteatoma (C) was observed in thirty nine (55.7%) and granulation (G) in eight patients (11.4%). Remaining patients had no active disease. Disease pattern assessed is shown in [Table 5] and [Table 6] with both groups had similar distribution (P = 0.733).
Table 5: Distribution of the Patients in Terms of Ossicular Status in Groups

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Table 6: Distribution of the Disease Pattern (Assessed Intraoperatively) in Groups

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Distribution of type of prostheses used is shown in [Table 7]. Thirty three patients were reconstructed with partial ossicular replacement prostheses (PORP) and rest with total ossicular replacement prostheses (TORP) [Table 7].
Table 7: Distribution of Type of Prostheses Used in Groups

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The Mean postoperative ABG was 18.89 dB for HA PORP, 16.83 dB for Ti PORP, 16.84 dB for HA TORP and 17.69 dB for Ti TORP. The results were highly significant (P < 0.01) at each frequency.

In canal wall up procedures, Success, in terms of an ABG of 20 dB or less, was achieved in 80% (n = 10) for HA PORP, 71.43% (n = 7) for Ti PORP, 100% (n = 5) for HA TORP and 80% (n = 5) for Ti TORP. No statistically significant difference was found in the two groups [Table 8].
Table 8: Percentage Success in Canal Wall Up Mastoidectomy with Tympanoplasty in Groups

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In canal wall down procedures, success was 62.5% (n = 8) for HA PORP, 75% (n = 8) for Ti PORP, 66.67% (n = 12) for HA TORP and 66.67% (n = 15) for Ti TORP. No statistically significant difference was found in the two groups [Table 9].
Table 9: Percentage Success in Canal Wall Down Mastoidectomy with Tympanoplasty in Groups

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CWU procedures showed a marked success (81.48%, n = 27) as compared to CWD (67.44%, n = 43) but these results were not statistically significant (0.198) [Table 10].
Table 10: Comparison of Percentage Success in Canal Wall Up and Canal Wall Down Mastoidectomy

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The highest success rate observed was 83.33% in Austin Kartush type C which was also the group with the least number of cases (n = 6). Most cases belonged to type A ossicular status (n = 27) with success rate of 70.37% (P = 0.91) [Table 11].
Table 11: Comparison of Percentage Success in Different Ossicular Status

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Overall, the success rate of HA prosthesis was 74.29% whereas the Ti group showed a rate of 71.43% (P = 0.788) [Table 12].
Table 12: Comparison of Overall Percentage Success in Groups

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  Discussion Top


Vast clinical studies have been conducted to determine the prosthetic efficacy of different alloplastic materials. HA prostheses and the newer Ti prostheses are most commonly used in otology practice. Only a few trials in the world and none in India have compared the two types of prostheses. Truy et al.[5] compared the Ti and HA prostheses and found no statistical significance between the results of the two implants but concluded to prefer the HA prostheses. However Coffey et al.[6] suggested Ti to be a better material for ossicular replacement prostheses (P = 0.012). Hence, the quest for the perfect prosthesis was the objective for undertaking this trial.

Total of 70 ossicular reconstructions were performed in 70 patients with either HA prostheses (n = 35) or Ti prostheses (n = 35) during a period of one year. The baseline variables were compared and no significant difference in the two groups was found (P > 0.05).

Analysis of the results was performed after confirming homogenecity of the pre-operative and per-operative variables in the two treatment groups. With ABG of less than 20 dB as a criterion of successful ossiculoplasty, HA success rates varied from 46%[7] to 75.7%[8] in TORP and from 68%[7] to 83.3%[8] in PORP. Taking all types of HA prostheses together, Goldenberg and Emmet [1] reported success rates below 50%. We also defined successful outcome as a post-operative ABG of <20 dB. Taking all types of prostheses together, we observed the overall success rate of 70%. A smaller series of revision cases by Downs et al.[9] demonstrated a higher success rate in a group of Ti prostheses compared to non-Ti, but was not sufficiently powered to show statistical difference in the percentage of cases achieving an ABG <20 dB. Prior studies [6],[10],[11],[12] have generally demonstrated favourable results when comparing Ti to other non-Ti prostheses in ossicular reconstruction. Their mean follow up time ranged from 12 months [10],[11] to 14.9 months.[6] Gardner et al.[13] reported clinically significant improvements in postoperative ABG in a large series of Ti cases vs. historical controls, but did not perform statistical comparisons of these outcomes. Neff et al.[14] showed success rates significantly favouring Ti over Plastipore in total ossicular reconstruction in a mean follow up period of 8 months. Hillman and Shelton [15] reported success rates favouring Plastipore with a follow up period of at least 2 to 3 months, although these results were not statistically significant. Truy et al.[5] reported non-significant results between the two types HA vs. Ti but favoured the HA prostheses.

In this study, the percentage of patients achieving success i.e., a post operative ABG of <20 dB was observed in 74.29% of cases in HA group and 71.43% of Ti group (P = 0.788). The percentage of patients achieving a post operative ABG of <10 dB was 25.71% in the HA group and 22.86% in the Ti group. There were no significant differences in results between HA and Ti prostheses for both Total as well as Partial prostheses (P > 0.05).

Focusing on frequency-specific outcomes, Zenner et al.[16] reported significantly improved success rates limited to 2 and 3 kHz with Ti vs. ceramic prostheses, but no advantage over gold prostheses. In our study, there were slightly better post-operative hearing outcomes in case of Ti PORP over higher frequencies 2 kHz and 4 kHz but they were statistically non-significant (P = 0.213, 0.406 resp.).

The patients were followed up for as long as possible, minimum for 3 months. In the follow up period, extrusion of the prostheses was observed in 3 patients.

It is important to mention that the cost considerations involved with both Ti and HA ossicular prostheses are the same. In this institution, the prostheses are in hospital supply. The operative time is comparable regardless of the type of prosthesis used.


  Conclusion Top


In the current study, both groups showed good hearing outcomes, low extrusion rates, good biocompatibility, and stability. Thus, endeavor must be made to perform some ossicular reconstruction during surgery. Comparing Ti and HA prostheses, we could not reach to a statistically significant outcome suggesting that the short-term hearing outcomes are similar for both groups. However, percentage analysis gives HA prostheses a slight edge over Ti prostheses. The choice of prostheses may be governed by the surgeon's preference, expertise, and their availability.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Goldenberg RA, Emmet JR. Current use of implants in middle ear surgery. Otol Neurotol 2001;22:145-52.  Back to cited text no. 1
    
2.
Wehrs RE. Hydroxylapatite implants for otologic surgery. Otolaryngol Clin North Am 1995;28:273-86.  Back to cited text no. 2
    
3.
Kartush JM. Ossicular chain reconstruction. Capitulum to malleus. Otolaryngol Clin North Am 1994;27:689-715.  Back to cited text no. 3
    
4.
Stupp CH, Stupp HF, Grün D. Replacement of ear ossicles with titanium prostheses. Laryngorhinootologie 1996;75:335-7.  Back to cited text no. 4
    
5.
Truy E, Naiman AN, Pavillon C, Abedipour D, Lina-Granade G, Rabilloud M. Hydroxyapatite versus titanium ossiculoplasty. Otol Neurotol 2007;28:492-8.  Back to cited text no. 5
    
6.
Coffey CS, Lee FS, Lambert PR. Titanium versus nontitanium prostheses in ossiculoplasty. Laryngoscope 2008;118:1650-8.  Back to cited text no. 6
    
7.
Grote JJ, Kuypers W, de Groot K. Use of sintered hydroxylapatite in middle ear surgery. ORL J Otorhinolaryngol Relat Spec 1981;43:248-54.  Back to cited text no. 7
    
8.
Grote JJ. Reconstruction of the middle ear with hydroxylapatite implants: Long-term results. Ann Otol Rhinol Laryngol Suppl 1990;144:12-6.  Back to cited text no. 8
    
9.
Downs BW, Pearson JM, Zdanski CJ, Buchman CA, Pillsbury HC. Revision ossicular reconstruction with the titanium Kurz prosthesis. Laryngoscope 2002;112(8 Pt 1):1335-7.  Back to cited text no. 9
    
10.
Alaani A, Raut VV. Kurz titanium prosthesis ossiculoplasty – Follow-up statistical analysis of factors affecting one year hearing results. Auris Nasus Larynx 2010;37:150-4.  Back to cited text no. 10
    
11.
Fong JC, Michael P, Raut V. Titanium versus autograft ossiculoplasty. Acta Otolaryngol 2010;130:554-8.  Back to cited text no. 11
    
12.
Iñiguez-Cuadra R, Alobid I, Borés-Domenech A, Menéndez-Colino LM, Caballero-Borrego M, Bernal-Sprekelsen M. Type III tympanoplasty with titanium total ossicular replacement prosthesis: Anatomic and functional results. Otol Neurotol 2010;31:409-14.  Back to cited text no. 12
    
13.
Gardner EK, Jackson CG, Kaylie DM. Results with titanium ossicular reconstruction prostheses. Laryngoscope 2004;114:65-70.  Back to cited text no. 13
    
14.
Neff BA, Rizer FM, Schuring AG, Lippy WH. Tympano-ossiculoplasty utilizing the Spiggle and Theis titanium total ossicular replacement prosthesis. Laryngoscope 2003;113:1525-9.  Back to cited text no. 14
    
15.
Hillman TA, Shelton C. Ossicular chain reconstruction: Titanium versus plastipore. Laryngoscope 2003;113:1731-5.  Back to cited text no. 15
    
16.
Zenner HP, Stegmaier A, Lehner R, Baumann I, Zimmermann R. Open Tübingen titanium prostheses for ossiculoplasty: A prospective clinical trial. Otol Neurotol 2001;22:582-9.  Back to cited text no. 16
    


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12]



 

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