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 Table of Contents  
ORIGINAL ARTICLE
Year : 2015  |  Volume : 21  |  Issue : 2  |  Page : 144-148

A comparative study of outcome of ossiculoplasty using cartilage graft, bone and different alloplasts in chronic otitis media


1 Department of ENT, N.R.S.M.C and H, Kolkata, West Bengal, India
2 Department of ENT, RMO Cum Clinical Tutor, Midnapore Medical College, West Bengal, India
3 Department of ENT, Murshidabad Medical College, West Bengal, India
4 Department of ENT, Bankura Sammilani Medical College, West Bengal, India
5 Department of ENT, Midnapore Medical College, West Bengal, India

Date of Web Publication20-Apr-2015

Correspondence Address:
Dr. Sudip Kumar Das
35B Moore Avenue, Kolkata - 700 040, West Bengal
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0971-7749.155314

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  Abstract 

Objective: The objective was to determine which material, among autologous cartilage, autologous incus and partial ossicular replacement prosthesis (PORP), gives better postoperative hearing result in ossiculoplasty. Study Design: Nonrandomized prospective cohort (longitudinal study). Settings: Tertiary referral center. Materials and Methods: Patients were selected from outpatients department with the clinical diagnosis of chronic suppurative otitis media with cholesteatoma or granulation tissue. Patients underwent necessary preoperative investigations including pure tone audiometry (PTA). Total 67 patients were selected for this study, among them 12 patients did not fit the selection criteria and 5 patients lost during follow-up. Hence, total 50 patients were taken in the study group. Intervention: Ossiculoplasty with cartilage, incus and PORP after modified radical mastoidectomy. Main Outcome Measure: Hearing results were measured by PTA-air bone gap (PTA-ABG) after 6 months of operation. Results: Selecting the criteria <20 dB ABG as success when stapes superstructure is present, cartilage has 60% success rate, incus has 73.68%, and PORP has 56.25% success. Extrusion rate of different prosthesis shows, PORP has 25%, cartilage has 20% extrusion. Incus has the lowest (5.26%) extrusion rate. Conclusion: Among the ossiculoplasty materials, autologous incus gives best postoperative hearing gain and lowest extrusion rate.

Keywords: Air bone gap, Cartilage, Incus, Ossiculoplasty, Partial ossicular replacement prosthesis


How to cite this article:
Mahanty S, Maiti AB, Naskar S, Das SK, Mandal S, Karmakar M. A comparative study of outcome of ossiculoplasty using cartilage graft, bone and different alloplasts in chronic otitis media. Indian J Otol 2015;21:144-8

How to cite this URL:
Mahanty S, Maiti AB, Naskar S, Das SK, Mandal S, Karmakar M. A comparative study of outcome of ossiculoplasty using cartilage graft, bone and different alloplasts in chronic otitis media. Indian J Otol [serial online] 2015 [cited 2017 Nov 24];21:144-8. Available from: http://www.indianjotol.org/text.asp?2015/21/2/144/155314


  Introduction Top


In the history of ossiculoplasty, the earliest recorded attempt to re-establish a connection between oval window and tympanic membrane in case of chronic suppurative otitis media (CSOM) with missing ossicle was in 1901. Since then plenty of materials have been used for ossicular substitution or reconstruction including both biological and alloplastic materials. Biological materials including autograft or homograft ossicles, cortical bone, teeth, cartilage. Thus, we had undertaken a prospective study to compare cartilage, bone and different alloplastic materials as the material of choice for reconstruction of the hearing mechanism. The ideal prosthesis for ossicular reconstruction should be biocompatible, stable, safe, and easily insertable and capable of yielding optimal sound transmission. In this study, we found autologous incus is a suitable prosthetic material than others.

Aim of study

The aim of our study is to determine, which is the most suitable material among autologous cartilage incus and partial ossicular replacement prosthesis (PORP) for ossiculoplasty after performing modified radical mastoidectomy. Among the above ossiculoplasty material which one gives the most hearing gain 6 months after the operation.

Study design

Nonrandomized prospective cohort (longitudinal study).


  Materials and Methods Top


The study was conducted in Nil Ratan Sircar Medical College and Hospital, Kolkata between January 2012 and July 2013. We had selected patients from outpatients department having clinical diagnosis of cholesteatoma and or granulation tissue. In this study, we selected total 67 patients, among them 12 patients did not fit our selection criteria and 5 patients lost during follow-up. Hence, we got total 50 patients for our study, among them 26 patients were male, and 24 were female. Exclusion criteria of the study were patients having complications like meningitis, subdural abscess, lateral sinus thrombophlebitis, otitic hydrocephalus and those patients who had lost stapes superstructures or intact ossicular chain. 12 such patients were excluded from our study. After making provisional diagnosis, patients underwent routine hematological and radiological examination. Preoperative hearing status was assessed by tuning fork test and pure tone audiometry (PTA). The average age of the patients was 14-61 years. All these patients underwent operation. The operation performed was modified radical mastoidectomy. During the operation, it was found that most of the patients have lost only long process of incus, but malleus and stapes present. Some patients had lost malleus and incus but stapes superstructure present. In most cases, we had remnant part or whole of the malleus where it was kept for maintaining the integrity of remnant tympanic membrane. In all patients cholesteatoma and granulation tissue thoroughly cleared. Incus with necrosed lenticular/long process was detached from incudomalleolar joint and taken out. It was then held with ossicle holding forceps such that the body of the incus was available for drilling and reshaping. Drilling was performed using 0.6 mm diamond burr [Figure 1]. The remnant long process was drilled to make it cylindrical in shape with a flat base. A socket was made drilling in the under surface of reloaded long process for engaging the head of stapes. Refashioned incus was interposed between handle of malleus and stapes superstructure. Drilling of facial ridge/posterior canal wall was done in such a way that >3 mm clearance was maintained between posterior canal wall and incus/cartilage/prosthesis to avoid the postoperative fixation by fibrous tissue. After this, prosthesis was placed over stapes head. Then grafting was done with temporalis fascia. In the case of PORP, a small piece of cartilage was placed between prosthesis and temporalis fascia graft. When cartilage used as graft material, we had harvested it from the floor of external auditory canal [Figure 2], [Figure 3] and [Figure 4]. For proper fitting of cartilage and incus, we used 0.6 mm diamond burr. During operation type of prosthesis was selected randomly. After the operation, patients were routinely followed-up at 1-week, 4 weeks, 3 months and 6 months. At the end of 6 months every patients underwent PTA testing.
Figure 1: Refashioning of incus

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Figure 2: Conchal cartilage harvesting

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Figure 3: Cartilage refashioning

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Figure 4: Placing of cartilage prosthesis over stapes head

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  Result and Analysis Top


Among the 50 patients in this study 15 underwent cartilage ossiculoplasty, 19 by autologous incus and 16 by PORP. The outcome was studied at the end of 6 months. All the patients were above 5 years of age. Age distribution of patientsare given in [Table 1].
Table 1: Age distribution

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Among 50 patients, 22 patients had a cholesteatoma, 18 patients had granulation tissue, 10 patients had edematous mucosa as pathology in the middle ear cleft. Preoperative hearing status was reported in [Table 2].
Table 2: Pre-operative hearing status

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In the above chart, it is shown that most of the patients had preoperative ABG lies in between 40 and 50 db. The postoperative hearing chart showing hearing status with different graft materials [Table 3].
Table 3: Post-operative hearing status

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From the above chart, it is seen that when incus is used as prosthetic material, only 21.05% patients has ABG > 30 db. Whereas cartilage has 40% and PORP has 43.75%.

[Table 4] shows success rate with different materials. Distribution of study population according to ossiculoplasty material and outcome (n = 50):

(<20db postoperative ABG is considered as a success).
Table 4: Success rate with different materials

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Extrusion rate in patients underwent ossiculoplasty with different materials (n = 50) shown in [Table 5].
Table 5: Extrusion rate with different graft materials

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  Discussion Top


The most common type of ossicular chain erosion encountered is necrosis of a long process of the incus because of its anatomical position and course of its blood supply. [1],[2] Various surgical techniques and materials have been used for ossicular chain reconstruction since 1950 but still there is no standardized technique and ideal material has been accepted worldwide. Three general classes of prosthesis are used today: autograft, homograft and allograft. Autograft prosthesis includes ossicles (incus, malleus), cartilage (septal, tragal), cortical bone. Advantages of autograft include a very low extrusion rate, no risk of transmitting disease, biocompatibility and no necessity for reconstruction. Displacement, complete absorption, small remnant size and possibility of harboring microscopic disease have been blamed as potential disadvantages of their use. [3]

Homografts are collected from cadavers or healthy person, stored in alcohol and then used for ossiculoplasty. Main disadvantages of these grafts are transmission of prions. For this reason and ready availability of ossicular prosthesis have minimize this practice. [4],[5]

Allograft prosthesis is readily available presculptured and made of synthetic materials such as hydroxyapatite, plastipore, titanium, glass-ceramics, etc., and are designed to be made biocompatible. Ossicular necrosis, extrusion, displacement and unsatisfactory hearing restoration have been encountered with virtually every type of design. Extrusion of prosthesis has been reported as high as 39%. However can be significantly reduced by placing cartilage or bone between the tympanic membrane and the prosthesis. [6]

Success in ossiculoplasty is determined by technical ability and to a large extends case selection. Much of the variability in the literature concerning hearing results after ossiculoplasty is due to lack of understanding and uniform reporting of those middle ear factors that influence the results. [7],[8] When the stapes superstructure is missing, the aim is to achieve a postoperative air-bone gap (ABG) <30 dB, when stapes is intact, an ABG < 20 dB is acceptable. While using these criteria, the incus interposition appears to be more successful than the use of the prosthesis. When the stapes superstructure and canal wall are present (80%). [9] Jha et al. in 2007-2009 performed a study of ossiculoplasty outcome after 2 and 5 months of operation in relation to ABG and suggested success rate among cartilage was 57%, in case of incus it was 59% and for plastic PORP and total ossicular replacement prosthesis (TORP) it was (40%). [10] Naragound et al. study on outcome of ossiculoplasty showed success rate of incus was 58%, where as in the case of PORP and TORP was (33%). [11] Gardner et al. published a retrospective study comparing the success results of PORP and TORP showing 48% in case of PORP and 24% in case of TORP when polyethylene base reconstruction was done. [12]

In our study, 50 cases were included. Among those 15 patients underwent cartilage ossiculoplasty, 19 patients with autologous incus, 16 patients with polyethylene PORP. Among these, success rate was 60% in case of cartilage, 73.68% in case of incus, 56.25% in case of PORP after 6 months of postoperative follow-up in relation to ABG < 20 dB when stapes superstructures is present, is considered as success. Jha et al. in their comparative study on ossiculoplasty described that the failure and extrusion in case of cartilage were 11.5%, in bone 5.9% and in plastic PORP it was 20%. Salter, Ritzer et al. also described higher rate of extrusion and failure when prosthesis was used. But to reduce the extrusion rate, the tragal cartilage is interposed between prosthesis and eardrum. Naragound et al. also described higher rate of extrusion among prosthesis (16.6%) than incus 0%. In our study likewise other literature, it showed higher extrusion rate in case of prosthesis. Among 15 cases of cartilage ossiculoplasty 3 cases of extrusion occurred (20%). In the case of incus 19 cases, 1 case of extrusion occurred (5.26%). For PORP 4 out of 16 cases, extrusion occurred (25%).

The mass and stiffness of prostheses may influence sound conduction in a frequency dependent manner. Studies by Meister et al. [13] and Kelly et al. [14] have suggested mass the most important variable, and prostheses weight should be as light as possible to optimize transmission of frequencies above 1000 Hz. More recent mathematical model by Zenner et al. [15] has determined that a mass of 5 mg or less provides maximum transfer of energy. The coupling of a prostheses to the tympanic membrane (or manubrium) to the stapes superstructure to footplate also influence overall result. The probable cause of incus giving the best postoperative result may be due to low impedance of incus compared to cartilage and PORP. Another reason may be the incudo-stapedeal joint moves best with the incus compared to cartilage and PORP. When incus is used as prosthesis, rocking movement of stapes footplate is maintained but in case of PORP, it is a transitional movement leads to less hearing gain compared to incus prosthesis. From an economic point of view a good quality of plastipore prosthesis cost around 4000-5000 rupees and for titanium prosthesis, it > 10,000 rupees. CSOM mainly affects poor socioeconomic patients and for them bearing of additional cost of the prosthesis become very difficult.


  Conclusion Top


Comparative study on outcome of ossiculoplasty using different materials in different ossicular status of middle ear had already been done by various authors previously. Though different prosthesis materials produce different vibrational response, a biocompatible, a mechanically stable implant produces improvement in hearing of patients.

In this study, we have shown that hearing results after ossiculoplasty with autologous incus produces significantly better as compared to those obtained with prosthesis. Furthermore, autologous incus has very low extrusion rate compare to other prosthesis.

Because of small sample size in this study, there remains a chance of statistical error. Further prospective clinical studies with large sample size are required to assess the long-term outcome of ossiculoplasty, but compliance for longer follow-up is a matter of concern. It is worthwhile to conclude that there is a need for many clinical trials with larger sample size and longer follow-up period to standardize the ossiculoplasty techniques and accept an ideal ossicular prosthesis.

With the continuing advances in our understanding of middle ear mechanics, the outcome of ossiculoplasty is improving. By paying careful attention to the principles of ossicular reconstruction and the lesions from basic sciences and applying them in clinical practice, it is possible to give more desirable hearing results for the patients.

 
  References Top

1.
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. 1
    
2.
Athanasiadis-Sismanis A, Poe DS. Ossicular chain reconstruction. In: Gulya AJ, Minor LB, Poe DS, Editors. Glasscock-Shambaugh Surgary of the ear. 6 th ed. Ch. 29. USA: People's Medical Publishing House, 2010. p. 489-500.  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.
Lubbe D, Fagan JJ. Revisiting the risks involved in using homograft ossicles in otological surgery. J Laryngol Otol 2008;122:111-5.  Back to cited text no. 4
    
5.
Glasscock ME 3 rd , Jackson CG, Knox GW. Can acquired immunodeficiency syndrome and Creutzfeldt-Jakob disease be transmitted via otologic homografts? Arch Otolaryngol Head Neck Surg 1988;114:1252-5.  Back to cited text no. 5
    
6.
Toner JC, Smyth GD, Kerr AG. Realities in ossiculoplasty. J Laryngol Otol 1991;105:529-33.  Back to cited text no. 6
    
7.
Black B. Ossiculoplasty prognosis: The spite method of assessment. Am J Otol 1992;13:544-51.  Back to cited text no. 7
    
8.
Albu S, Babighian G, Trabalzini F. Prognostic factors in tympanoplasty. Am J Otol 1998;19:136-40.  Back to cited text no. 8
    
9.
Dornhoffer JL. Hearing results with the Dornhoffer ossicular replacement prostheses. Laryngoscope 1998;108 (4 Pt 1):531-6.  Back to cited text no. 9
    
10.
Jha S, Mehta K, Prajapati V, Patel D, Kharadi P. A comparative study of ossiculoplasty by using various graft materials. NJIRM 2011;2:53-7.  Back to cited text no. 10
    
11.
Amith I, Naragund RS Mudhol, Harugop AS, Patil PH. Ossiculoplasty with autologous incus vs prosthesis: A comparison of anatomical and functional results. Indian Journal of Otology 2011;17:75-79.  Back to cited text no. 11
    
12.
Gardner EK, Jackson CG, Kaylie DM. Results with titanium ossicular reconstruction prostheses. Laryngoscope 2004;114:65-70.  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
    
15.
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. 15
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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