International Journal of Pediatric Otorhinolaryngology 85 (2016) 103–106
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Results of ossicular chain reconstruction with glass ionomer cement in pediatric patients ¨ zcan Dog˘an Atan*, Hu¨seyin Dere, Ali Rıza Yamur, Ku¨rs¸at Murat O Department of Otorhinolaryngology, Ankara Numune Training and Research Hospital, Ankara, Turkey
A R T I C L E I N F O
A B S T R A C T
Article history: Received 15 January 2016 Received in revised form 15 March 2016 Accepted 18 March 2016 Available online 28 March 2016
Objective: The aim of our study was to analyze the hearing results of ossicular chain reconstruction in incus long process defects in pediatric patients. Methods: This retrospective study included 15 pediatric patients that had incus long process defect due to chronic otitis media or adhesive otitis, and repaired with glass ionomer cement between 2009 and 2015. The audiological tests (air conduction thresholds, bone conduction thresholds, air bone gap) obtained preoperatively and one year after surgery were compared. In addition, preoperative and postoperative air bone gap differences were estimated to determine hearing gain. Results: Mean air conduction and air bone gaps decreased significantly one year after surgery when compared to the preoperative values (p< 0.001 for both). Mean hearing gain was 20.33 6.36 dB one year after surgery. Conclusion: Use of glass ionomer cement to repair incus long process defects is a suitable method that improves hearing in pediatric patients. Further large studies that compare glass ionomer cement ossiculoplasty with other ossicular reconstruction methods are needed. ß 2016 Elsevier Ireland Ltd. All rights reserved.
Keywords: tympanoplasty hearing reconstruction ossicular chain
1. INTRODUCTION Long process of incus is the most frequently involved part of the ossicular chain in chronic otitis media, adhesive otitis, and trauma since its vascular supply is limited compared to other ossicles. Therefore, ossicular reconstruction is usually necessary for incus long process defects [1]. Various materials and methods have been used to repair incus long process defects including incus interposition, partial ossicular replacement prosthesis (PORP), cortical bone, cartilage, and glass ionomer cement (GIC) [2]. GIC is a hybrid material that contains aluminum fluorosilicate in a hydrogel mattress. Its advantages are ease of use, low cost, and a high biocompatibility [3,4]. GIC was first used for repair of dental defects, however it is currently frequently used in otological and neuro-otological surgery. Apart from ossicular chain reconstruction, it is used for repair of tegmen defects, outer ear canal reconstruction, mastoid obliteration, and stabilization of some hearing prostheses [5]. Various studies in current English literature reported different hearing results for incus long process defect repair with GIC in
* Corresponding author. Ankara Numune Education and Research Hospital, Ankara, Turkey. Tel.: +0555 515 1208; fax: +90 312 310 3460. E-mail address:
[email protected] (D. Atan). http://dx.doi.org/10.1016/j.ijporl.2016.03.027 0165-5876/ß 2016 Elsevier Ireland Ltd. All rights reserved.
adults [6–9]. However, to our knowledge, no studies in the current English literature investigated hearing results with this material in children in case of incus long process defects. In this study, we aimed to present hearing results of pediatric patients that had incus long process repair with GIC, and discuss our results in the light of the current literature. 2. MATERIALS AND METHODS 2.1. Subjects This retrospective study included 15 pediatric patients that had incus long process defect due to chronic otitis media or adhesive otitis, and repaired with glass ionomer cement between 2009 and 2015. The ages of the patients ranged between 10 and 16 years. Adhesive otitis was considered if the tympanic membrane was adhered to incus, stapes or promontorium. Chronic otiti media was considered in presence of middle ear infection for more than 3 months together with tympanic membrane perforation. Exclusion criteria were revision ear surgery, stapes fixation due to otosclerosis, tympanosclerosis, or congenital factors, presence of cholesteatoma, or any ossicular chain defect except for an incus long process defect. The patients with incus long process defect due to adhesive otitis or chronic otitis, and normal stapes and malleus were
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selected. Bone cement was used when the length of incus long arm defect was 3 mm at maximum. The tympanoplasty procedure was performed under general anesthesia, using a postauricular incision. The tympanomeatal flap was elevated, and the middle ear was exposed. The posterosuperior wall of the outer ear canal was removed with a curette if necessary, to see long process of incus and head of stapes. Mastoidectomy was not performed in any of the patients. The defect in long process of incus was repaired using GIC (Ketac-Cem, Espe Dental AG, Seefeld, Germany) (Figs. 1 and 2). GIC is composed of a sterile powder and a liquid. Two components are mixed on a metal surface in sterile conditions for 10 s during surgery. The mixture must be used within 2 minutes. The mixture is placed between the defective incus long process and stapes head using a thin pick to form an incudostapedial bridge. The GIC gets hard 5 min after its application. Temporal muscle fascia was used as a graft in patients with chronic otitis media. The posterosuperior wall of the outer ear canal was supported with a piece of cartilage in patients with adhesive otitis, and the defective tympanic membrane was repaired with cartilage graft when needed. The grafts were placed using underlay technique. Gelfoam was placed into the outer ear [(Fig._1)TD$IG]
canal. There were no major postoperative complications in any of the patients, and they were discharged on postoperative day 1. 2.2. Audiometric Assessment Pure tone audiometric analyses were performed using AC-40 clinical audiometer (Inter acoustic, Denmark). The mean bone and air conduction thresholds (500, 1000, 2000, 4000 and 8000 Hz) were calculated. The air bone gap (ABG) was calculated by subtracting the mean air conduction threshold (mean of the air thresholds at 500, 1000, 2000 and 4000 Hz) from the mean bone conduction threshold (mean of the bone thresholds at the same frequencies). In addition, the difference of preoperative and postoperative ABG was calculated to determine ABG gain. Postoperative audiological tests were performed one year after surgery. The mean air thresholds, the mean bone thresholds, and mean ABG were calculated for every patient on preoperative and postoperative audiological tests. In addition, preoperative and postoperative ABG differences were calculated, and the patients were divided into 2 groups as the ones with a hearing gain <20 decibel Hearing Level (dB HL) and the ones with a hearing gain >20 dB HL, and the patients were analyzed. Preoperative and postoperative data were compared statistically. 2.3. Statistical Analysis Statistical analysis was carried out using SPSS, version 21.0 software program (SPSS Inc., Chicago, IL, USA). Continuous data were presented as mean standard deviation (SD). Categorical variables were presented as percentages. Continuous variables with a normal distribution were analyzed with Student t-test while Mann Whitney U was used for the variables that did not have normal distributions. P values less than 0.05 were considered as statistically significant.
[(Fig._2)TD$IG]
3. RESULTS
Fig. 1. Incus long process defect in a patient with adhesive otitis.
There were 7 girls (47%), and 8 boys (53%) in the study group. The mean standard deviation (SD) age of the patients was 13.26 1.90 (range: 10-16) years (Table 1). The mean SD preoperative and postoperative air thresholds of the patients were 44.66 10.19 dB HL and 21.93 6.90 dB HL, respectively, and the difference was statistically significant (p < 0.001). The mean SD preoperative bone threshold was 10.53 5.90 dB HL while this value was 8.66 4.02 dB HL postoperatively. The difference was not statistically significant (p= 0.160). The mean SD preoperative and postoperative ABG were 34 6.67 dB HL and 13 5.90 dB HL respectively, and the difference was statistically significant (p< 0.001) (Table 2). It was evident that hearing of the patients improved significantly after surgery. Table 1 The characteristics of the study population.
Fig. 2. GIC repair of the incus long process defect.
Patient characteristics
Mean SD
Gender Male Female Age (years) Preoperative air conduction PTA Postoperative air conduction PTA Preoperative bone conduction PTA Postoperative bone conduction PTA Preoperative ABG Postoperative ABG
8 (53%) 7 (47%) 13.26 1.90 44.66 10.19 21.93 6.90 10.53 5.90 8.66 4.02 34 6.67 13 5.90
PTA: Pure tone average, ABG: Air bone gap, SD: Standard deviation[5_TD$IF]. * p < 0.05 was considered significant.
p value
< 0.001*[3_TD$IF] 0.160 < 0.001*[4_TD$IF]
D. Atan et al. / International Journal of Pediatric Otorhinolaryngology 85 (2016) 103–106 Table 2 Postoperative hearing gains of the study group.
Adhesive otitis group
Chronic otitis group Total
Table 3 Preoperative impairment groups and postoperative cathegories of our patients.
>20 dB HL
<20 dB HL
Hearing gain (dB HL)
5 (63%)
3 (37%)
19.87 5.40
4 (57%) 9 (60%)
3 (43%) 6 (40%)
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p value
Preoperative group
Number of patients
Postoperative cathegories
0.778
Normal Group 1 Group 2 Group 3
1 9 1 4
1 8 NA NA
abcd
20.85 7.73 20.33 6.36
NA NA NA 3
NA 1 NA 1
NA NA 1 NA
NA: not applicable
The mean SD hearing gain after surgery using GIC was 20.33 6.36 dB HL (minimum 9 dB HL, maximum 34 dB HL). The study group was divided into two subgroups as the ones with a hearing gain <20 dB HL and the ones with a hearing gain >20 dB HL. Nine (60%) patients had >20 dB HL, and 6 (40%) patients had <20 dB HL hearing gain after surgery. When the patients that had adhesive otitis and GIC repair of incus long process were taken into account, there was >20 dB HL gain in 5 (63%) patients, and <20 dB HL gain in 3 (37%) patients. The mean SD hearing gain was 19.87 5.40 dB HL in the group that had surgery due to adhesive otitis. There was more than >20 dB HL gain in 4 (57%) patients with chronic otitis media that had GIC repair of incus long process, however there was <20 dB HL gain in 3 (43%) patients, and the mean postoperative hearing gain was 20.85 7.73 dB HL. The adhesive otitis and chronic otitis media groups were not different for hearing gain (p= 0.778) (Table 2). The hearing results of our patients were analyzed with Glaskow Benefit Plot, which is an internationational agreed standard (10). Hearing was measured in relation with pure tone air conduction averages in the operated and non-operated ears. The averages of 0,5, [(Fig._3)TD$IG] 1, 2 kHz air conduction thresholds were used for this purpose.
3.1. Preoperative Impairment Groups Patients’ preoperative AC threshold is likely to fall into one of the three main preoperative impairment groups. Group 1. Unilateral hearing impairment: Asymmetric threshold Group 2. Bilateral hearing impairment: Asymmetric threshold Group 3. Bilateral hearing impairment: Symmetric threshold (10). 3.2. Post Operative Categories Post operatively, the patients hearing could change into one of the four categories. Category a: Bilateral normal hearing. Category b: Unilateral normal hearing. Category c: Operated ear improves, but is still impaired. Category d: Symmetric but impaired thresholds (10). Pre- and postoperative hearing statuses of our patients are presented in Table 3 and Fig. 3. Eight of 9 patients that were in Group 1 and had unilateral hearing loss become Category a, i.e. had normal hearing postoperatively. In Group 2, one patient with
Fig. 3. Preoperative impairment groups and postoperative cathegories of our patients in Glaskow benefit plot. (x: preoperatif, o: postoperatif).
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asymmetrical hearing loss was included in bilateral symmetrical hearing loss category after surgery. Three of 4 patients in Group 3 with bilateral symmetrical hearing loss were included in the Category c (Operated ear improved, but is still impaired), and one patient was included in Category d (Symmetric but impaired thresholds). 4. DISCUSSION The results of this study indicated that pediatric patients that had ossicular reconstruction with GIC had significant improvement in their long-term hearing. In addition, most of the pediatric patients included in the study had more than 20 dB HL gain in ABG. Most of the studies in the literature regarding incus long process repair have been performed on adults, and compared GIC repair with incus interposition. Dere et al. compared long term hearing results of GIC repair and incus interposition in incus long process defects. The hearing gains were similar in two groups. The authors reported an average hearing gain of 7 dB HL gain in patients that had GIC repair [6]. Yazıcı et al. compared GIC and incus interposition in adult patients that had type 2 tympanoplasty. They indicated that GIC repair was more successful than incus interposition. In addition, a mean gain of 17 dB was reported in patients that had incus long process repair with GIC [7]. Kum et al. found similar hearing results for GIC repair and incus interposition in adult patients with incus long process defects. In addition, the mean hearing gain was found as 15 dB HL in patients that had GIC repair [11]. In our study, we found the mean hearing gain as 20 dB HL one year after pediatric tympanoplasty with GIC repair. We did not find any studies in the literature that compared GIC repair and incus interposition in pediatric incus long process defects. Further studies on large study groups are needed to compare those two techniques in the pediatric population. Baylancicek et al. compared long-term hearing results of bone cement repair and PORP for incus long process defects in adults. The hearing gains were found similar in two groups. The mean hearing gain was reported as 17 dB HL in the bone cement group. In that group, hearing gain was <20 dB HL in 90% of the patients, and >20 dB HL in 10% of them [8]. In our study, we found >20 dB HL gain after GIC repair in 60%, and <20 dB HL gain in 40% of the pediatric patients. Nevoux et al. performed cartilage ossiculoplasty in their large pediatric series with incus defects. The defective incus was removed, and a composite cartilage graft was placed between head of stapes and malleus. The mean hearing gain was 6 dB HL one year after surgery [12]. Daniels et al. investigated long-term hearing results of pediatric patients that were treated with tympanoplasty and PORP application. ABG was 20 dB HL in 77% of the patients after 6 months, however this rate was 63% after
one year. The authors concluded that hearing gain decreased in long term [13]. We compared preoperative hearing of the patients with hearing one year after surgery. Further studies may be conducted to compare early and long term hearing results of incus long process repair with GIC. Our study has some limitations. First, the number of patients is small. Absence of comparison of GIC repair with other techniques, and absence of results more than one year after surgery are other limitations. Further new studies on pediatric population would be beneficial to compare long-term results of GIC repair for incus long process defects with other ossicular chain reconstruction methods such as incus interposition and PORP.
5. CONCLUSION The results of our study indicated that GIC reconstruction of incus long process defects is an easy-to-use, and low-cost method with good hearing results. No financial resources were used for this article. There are no conflicts of interest[1_TD$IF].
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