- Email: [email protected]
Stabilization of total ossicular replacement prosthesis using cartilage “shoe” graft
AMERI CAN JOURNAL OF OTOLAR YNGOLOGY–H E AD AN D N E CK M EDI CI N E AN D S U RGE RY 3 7 ( 2 0 16 ) 74–7 7
Available online at www.sciencedirect.com
ScienceDirect www.elsevier.com/locate/amjoto
Stabilization of total ossicular replacement prosthesis using cartilage “shoe” graft☆,☆☆ Nihal Efe Atila, M.D. a , Korhan Kilic, M.D. a,⁎, Muhammed Sedat Sakat, M.D b, c , Enver Altas, M.D. b , Harun Ucuncu, M.D. b , Yunus Emre Bulut, M.D. c a b c
Palandoken State Hospital, Otorhinolaryngology Clinics, Erzurum, Turkey Ataturk University, Faculty of Medicine, Department of Otorhinolaryngology, Erzurum, Turkey Gaziosmanpasa University, Faculty of Medicine, Department of Public Health, Tokat, Turkey
ARTI CLE I NFO
A BS TRACT
Article history:
Purpose: We aimed to determine the effect of a cartilage shoe graft placed between the foot of
Received 26 October 2015
the TORP and the stapes footplate on hearing improvement and long-term displacement rates. Materials and methods: Patients who underwent TORP ossiculoplasty were divided into two groups. The TORP-alone group consisted of 32 patients who underwent TORP placement without cartilage shoe graft and served as the control group. The study group consisted of 56 patients who underwent placement of cartilage shoe graft together with TORP. Pure-tone audiometry was administered to all patients before and 3, 6 and 12 months after surgery. Indications for surgery, surgical technique used, postoperative complications, and air and bone conduction thresholds at 500, 1000, 2000 and 4000 Hz were recorded for all patients. Results: No significant difference in postoperative air–bone gaps was observed between the groups. The number of patients with air–bone gaps less than 20 dB was 14 (25%) in the study group and 8 (25%) in the control group. There was no significant difference in changes in air–bone gaps between the groups. Dislocation of the prosthesis was observed in 3 patients in the study group (5.3%) and 4 in the control group (12.5%). There was less dislocation of the prosthesis in the study group, but the difference was not statistically significant. Conclusion: Placement of a cartilage graft between the footplate of the stapes and the foot of the prosthesis may have positive effects on long-term hearing improvement and rates of prosthesis displacement. Further research with larger patient numbers is needed to identify the advantages of shoe graft. © 2016 Elsevier Inc. All rights reserved.
1.
Introduction
The human ossicular chain acts as a cantilever mechanism to permit reliable conduction of sound energy from the tympanic
☆
membrane to the oval window. An intact ossicular chain is required for successful hearing together with an intact, vibrating tympanic membrane and a ventilated middle ear. Defect in the ossicular chain is reconstructed using ossicular
All authors declare that there is no conflict of interest. The authors declare that they have nothing to disclose. ⁎ Corresponding author at: Palandoken State Hospital, Otorhinolaryngology Clinics, Erzurum, Turkey. Tel.: +90 5326564191. E-mail address: [email protected] (K. Kilic).
☆☆
http://dx.doi.org/10.1016/j.amjoto.2015.12.001 0196-0709/© 2016 Elsevier Inc. All rights reserved.
AMERI CA N JOURNAL OF OT OLAR YNGOLOGY–H E AD AN D N E CK M EDI CI N E AN D S U RGE RY 3 7 ( 2 0 16 ) 74–7 7
reconstruction prosthesis. There are two main types of prosthesis, partial ossicular reconstruction prosthesis (PORP) and total ossicular reconstruction prosthesis (TORP). The stapes superstructure is important in reconstruction choices. PORP is used in the presence of an appropriately oriented stapes superstructure. The superstructure provides a stable attachment point for the prosthesis. When the stapes superstructure is inappropriately oriented or damaged, TORP must be used. The ideal TORP must have similar acoustic characteristics and long-term stabilization to the human ossicular chain. In order to achieve successful hearing outcomes after ossiculoplasty, the prosthesis must be attached in a firm and stable manner. A loose connection results in inefficient energy transfer and a high risk of displacement. Prosthesis displacement is the second most important cause of ossiculoplasty failure, after persistence of middle ear disease [1]. A TORP consists of three main parts: a head in contact with the tympanic membrane, a thin shaft and a wider base of the shaft, the foot, which lies over the footplate. Either of these two connections may be the cause of displacement after surgery, resulting in a persistent postoperative air–bone gap. Several methods, intended to minimize the rate of ossicular displacement after reconstruction have been described. One consists of two-point fixations with cartilage grafting. Two-point fixation refers to fixation of the head of the prosthesis to the tympanoplasty graft and of the foot of the prosthesis to the footplate [2]. Establishing a stable TORPfootplate coupling is mandatory for successful reconstruction [3]. The purpose of this study was to determine the effect of a cartilage shoe graft on hearing improvement and long-term displacement rates. We prepared a cartilage shoe graft in order to achieve stable coupling between the foot of the TORP and the stapes footplate.
2.
Materials and methods
2.1.
Subjects
The study was performed at the Ataturk University Department of Otorhinolaryngology, Erzurum, between October 2013 and February 2015. All patients undergoing TORP ossiculoplasty were included. Patients with previous stapedectomy or stapedotomy or a history of aural atresia were excluded. Eighty-eight patients were included in the study. Age and gender, indications for surgery, surgical technique used, and postoperative complications were recorded for all patients. Patients were divided into two groups. The TORP-alone group consisted of 32 patients who underwent TORP placement without cartilage shoe graft and served as the control group. The study group consisted of 56 patients who underwent placement of cartilage shoe graft together with TORP. Pure-tone audiometry was administered to all patients before and 3, 6 and 12 months after surgery. Air and bone conduction thresholds were recorded at 500, 1000, 2000 and 4000 Hz. Pure-tone averages were calculated by averaging the thresholds for 500, 1000, 2000 and 4000 Hz for air and bone conduction. The air–bone gap was calculated for each patient as the difference between average air conduction and average bone conduction.
2.2.
75
Surgical technique
Under general anesthesia, all patients underwent type 3 tympanoplasty using a postauricular approach. Depending on the surgeon’s preference at the time of surgery, canal wall up or canal wall down procedures were employed. In the control group, a cartilage graft was formed from tragal cartilage and placed between the tympanoplasty graft and the head of the TORP as a “hat graft” and attached with bone cement. In the study group, as well as the hat graft, another piece of the cartilage was reshaped and placed between the foot of the TORP and the footplate as a “shoe graft” and attached with bone cement. In both groups, after preparation, the TORP was placed between the oval window and tympanic graft. The fascia of the temporal muscle was used for reconstruction of the tympanic membrane. All surgeries were performed by the same senior surgeon (E. A., with 20 years of experience).
2.3.
Statistical analysis
Statistical analyses were performed on SPSS 15.0 for Windows. The χ2 test was used to compare categorical variables, the t test for interval levels and analysis of variance when more than one independent variable was involved. Success of surgery is based on a postoperative air–bone gap of less than 20 dB. The rates of successful outcomes were compared between the groups using the χ2 test. P < 0.05 was considered statistically significant for all tests.
3.
Results
Eighty-eight patients were included in the study. The TORPalone group consisted of 32 patients (20 female, 12 male) and the study group of 56 (22 female, 34 male). Patients’ ages ranged from 12 to 68 with a median age of 34. There was no statistically significant difference in terms of age or gender between the groups. Patients’ demographic properties are summarized in Table 1. The main pathology was cholesteatoma, present in 28 patients in the study group (50%) and 18 in the control group (56.3%). Canal wall down procedures were performed in 24 patients from the study group (42.9%) and 14 from the control group (43.8%). There was no statistically significant difference in primary disease or surgical procedure between the groups (Table 1). According to the preoperative audiograms, there was no significant difference in preoperative air conduction, bone conduction or air–bone gap between the groups (Table 2). In
Table 1 – Comparison of the demographic properties of patients in study and control groups.
Average age Range of age Male/female Choleasteatoma CWD/CWU
Control (n = 32)
Study (n = 56)
35.7 18–60 12/20 18 14/18
33.1 12–68 34/22 28 24/32
p > 0.05 p > 0.05 p > 0.05 p > 0.05
76
AMERI CAN JOURNAL OF OTOLAR YNGOLOGY–H E AD AN D N E CK M EDI CI N E AN D S U RGE RY 3 7 ( 2 0 16 ) 74–7 7
Table 2 – Comparison of audiogram results of control and study groups.
Preoperative air conduction Preoperative bone conduction Preoperative air–bone gap Air–bone gap at postoperative 3rd month Air–bone gap at postoperative 6th month Air–bone gap at postoperative 12th month
Control
Study
69.3 18.5 50.7 31 29.3 29.9
69.7 19.1 50.5 33.6 31.5 29.9
the control group, there was a statistically significant difference between the preoperative air–bone gap and those at the 3rd, 6th and 12th month postoperatively. In addition, the air–bone gap at the postoperative 12th month differed significantly from that at the postoperative 3rd month. In the study group, the air– bone gaps at postoperative months 3, 6 and 12 differed significantly from the preoperative air–bone gap, as in the control group. Additionally, the air–bone gap at the postoperative 12th month differed significantly from that at the postoperative 3rd month. There was no significant difference in postoperative air–bone gaps between the groups (Table 2). TORP ossiculoplasty showed significant improvement in hearing. Table 3 showed the decibel gain and improvement in air–bone gap at postoperative 12th month. The number of patients with air–bone gaps less than 20 dB was 14 (25%) in the study group and 8 (25%) in the control group. Twenty-six patients (46.4%) in the study group and 14 (43.8%) in the control group had air–bone gaps less than 30 dB. There was no significant difference in changes in air–bone gaps between the groups. A second-look explorative tympanotomy was performed to the patients who had an unexpected recurrent air–bone gap within follow-up period. Dislocation of the prosthesis was diagnosed by this second-look approach. Dislocation of the prosthesis was observed in 3 patients in the study group (5.3%) and 4 in the control group (12.5%). There was less dislocation of the prosthesis in the study group, but the difference was not statistically significant (p = 0.025).
4.
Discussion
The aim of surgical treatment of chronic otitis media is to establish a healthy, ventilated middle ear and functional sound conduction mechanism. In patients with ossicular chain destruction, sound conduction can be achieved by ossicular chain reconstruction. This reconstruction can be performed by use of autologous incus or malleus grafts,
Table 3 – Comparison of preoperative and postoperative 12th month audiometric results of the patients.
Preoperative air conduction Postoperative air conduction Decibel gain Preoperative air–bone gap Postoperative air–bone gap Improvement in air–bone gap
Control
Study
69.3 52.8 16.5 50.7 29.9 20.8
69.7 50.8 18.9 50.5 29.9 20.6
± 12.3 ± 18.3 ± 9.6 ± 12.8
± 17.44 ± 18.6 ± 9.9 ± 11.3
± ± ± ± ± ±
12.3 10.8 9.6 12.3 13.1 12.8
± ± ± ± ± ±
17.44 13.9 9.9 12.8 11.2 11.3
p p p p p p
> > > > > >
0.05 0.05 0.05 0.05 0.05 0.05
including incus interpositioning [4]. However, in the absence of the malleus and incus, ossicular reconstruction prosthesis must be employed. The first middle ear prosthesis was introduced by Wullsteinin 1952 [4]. Several materials have subsequently been used for reconstruction of the ossicular chain, such as titanium, hydroxyapatite, plastipore and bone cement. The main requirements of a replacement material are biocompatibility and stability [2]. Bahmad et al. described the histopathology of ossicular implants and determined no foreign body reaction and inflammation in hydroxyapatite prostheses [5]. In recent years, titanium has become a favorite material for reconstruction due to its biocompatibility. Similarly, hydroxyapatite prostheses act like middle ear bones and do not cause osteogenic reaction. Studies comparing the use of hydroxyapatite and titanium prostheses have shown no difference in short- or long-term effectiveness between these two materials [6–8]. In our study, we used hydroxyapatite TORP for reconstruction of the ossicular chain. In patients with ossicular reconstruction, surgical success is defined as providing a postoperative air–bone gap less than 20 dB [2,4]. Since many other factors including primary disease, ventilation of the middle ear, and persistence of the disease may affect auditory outcomes after TORP ossiculoplasty, success rates after TORP ossiculoplasty in the literature differ. However, the general rate of success is between 25% and 60% [9–12]. In our study, 25% of the study group and 25% of the control group had postoperative air– bone gaps less than 20 dB. In addition, 46% of patients in the study group and 43% of patients in the control group had postoperative air–bone gaps less than 30 dB. The overall average hearing improvement was 18.4 dB (18.6 dB in the study group, 18.3 dB in the control group). Our results were similar to those published previously. The most important problem after ossiculoplasty is a persistent or recurrent air–bone gap, which mostly derives from persistence of the disease or displacement of the prosthesis [2]. Recent studies have focused on reducing the rate of prosthesis displacement after ossiculoplasty. Lateral stabilization of the prosthesis with a cartilage placed between the tympanic membrane and the prosthesis is a widely accepted method. Displacement rates have been reported to decrease to less than 2% with cartilage lateral stabilization [9,13–15]. However, it is also important to stabilize the prosthesis on the center of the footplate. Several methods have been introduced to fix the prosthesis to the footplate. Berenholz et al. used areolar tissue between the prosthesis shaft and footplate to avoid displacement and reported a postoperative air–bone gap less than 20 dB in 44% of patients [16]. Bremke et al. used a cartilage sandwich technique to stabilize the prosthesis over the footplate. They described
AMERI CA N JOURNAL OF OT OLAR YNGOLOGY–H E AD AN D N E CK M EDI CI N E AN D S U RGE RY 3 7 ( 2 0 16 ) 74–7 7
their method as safe and reliable in ossiculoplasty [17]. Beutner et al. described a new technique for stabilization of the TORP at the center of the footplate, which they referred to as the cartilage shoe. In this technique, they placed a cartilage between the footplate and prosthesis to stabilize the TORP on the center of the footplate. They concluded that using the cartilage shoe may be beneficial in preventing TORP dislocation [3]. A titanium footplate shoe was used instead of cartilage in other studies. Fayad et al. reported better hearing results after ossiculoplasty with a titanium footplate shoe and TORP compared to TORP alone, but the difference was not statistically significant [4]. A similar shoe prosthesis was used by Cox et al., who also reported higher rates of success in patients treated with TORP+footplate shoe [2]. In our study, we used a cartilage shoe graft for stabilization of the prosthesis over the footplate in the experimental group. The hearing results in both groups were similar to those in previous studies. There was no difference in hearing outcomes between the groups. In addition, patients’ primary pathological findings and the surgical procedure performed did not affect the hearing results. At long-term follow-up, there was no decrease in sound conduction or air–bone gap at the postoperative 12th month. Less displacement of the prosthesis was observed in patients treated with TORP+shoe, but the difference was not statistically significant.
5.
Conclusion
Ossicular reconstruction remains a challenging problem. Although our study tended to favor the use of a cartilage graft placed between the footplate of the stapes and the foot of the prosthesis to have positive effects on long-term hearing improvement and rates of prosthesis displacement, the results were not statistically significant. Further research with larger patient numbers is needed to identify the advantages of shoe graft.
REFERENCES
[1] Yung M. Long-term results of ossiculoplasty: reasons for surgical failure. Otol Neurotol 2006;27(1):20–6.
77
[2] Cox MD, Russell JS, Dornhoffer JL. TORP ossiculoplasty outcomes with and without a stapes footplate prosthesis. Otolaryngol Head Neck Surg 2015;152(3):501–5. http://dx.doi. org/10.1177/0194599814564538. [3] Beutner D, Luers JC, Huttenbrink KB. Cartilage 'shoe': a new technique for stabilisation of titanium total ossicular replacement prosthesis at centre of stapes footplate. J Laryngol Otol 2008;122(7):682–6. [4] Fayad JN, Ursick J, Brackmann DE, et al. Total ossiculoplasty: short- and long-term results using a titanium prosthesis with footplate shoe. Otol Neurotol 2014;35(1):108–13. [5] Bahmad Jr F, Merchant SN. Histopathology of ossicular grafts and implants in chronic otitis media. Ann Otol Rhinol Laryngol 2007;116(3):181–91. [6] Lee JI, Yoo SH, Lee CW, et al. Short-term hearing results using ossicular replacement prostheses of hydroxyapatite versus titanium. Eur Arch Otorhinolaryngol 2014;6 [Epub ahead of print]. [7] Truy E, Naiman AN, Pavillon C, et al. Hydroxyapatite versus titanium ossiculoplasty. Otol Neurotol 2007;28(4):492–8. [8] Yung M, Smith P. Titanium versus nontitaniumossicular prostheses-a randomized controlled study of the mediumterm outcome. Otol Neurotol 2010;31(5):752–8. [9] Slater PW, Rizer FM, Schuring AG, et al. Practical use of total and partial ossicular replacement prostheses in ossiculoplasty. Laryngoscope 1997;107(9):1193–8. [10] Murphy TP. Hearing results in pediatric patients with chronic otitis media after ossicular reconstruction with partial ossicular replacement prostheses and total ossicular replacement prostheses. Laryngoscope 2000;110(4):536–44. [11] Gardner EK, Jackson CG, Kaylie DM. Results with titanium ossicular reconstruction prostheses. Laryngoscope 2004; 114(1):65–70. [12] Ho SY, Battista RA, Wiet RJ. Early results with titanium ossicular implants. Otol Neurotol 2003;24(2):149–52. [13] Wang X, Song J, Wang H. Results of tympanoplasty with titanium prostheses. Otolaryngol Head Neck Surg 1999;121:606–9. [14] Kim HH, Wiet RJ. Preferred technique in ossiculoplasty. Oper Tech Otolaryngol Head Neck Surg 2003;14:243–6. [15] Mardassi A, Deveze A, Sanjuan M, et al. Titanium ossicular chain replacement prostheses: prognostic factors and preliminary functional results. Eur Ann Otorhinolaryngol Head Neck Dis 2011;128(2):53–8. [16] Berenholz L, Burkey J, Lippy W. Total ossiculoplasty: advantages of two-point stabilization technique. Int J Otolaryngol 2012;2012:346260. [17] Bremke M, Hüttenbrink KB, Beutner D. The sandwich cartilage shoe technique for ossicular reconstruction in a case of an unsecure stapes footplate. Laryngoscope 2011; 121(9):1950–2.
Available online at www.sciencedirect.com
ScienceDirect www.elsevier.com/locate/amjoto
Stabilization of total ossicular replacement prosthesis using cartilage “shoe” graft☆,☆☆ Nihal Efe Atila, M.D. a , Korhan Kilic, M.D. a,⁎, Muhammed Sedat Sakat, M.D b, c , Enver Altas, M.D. b , Harun Ucuncu, M.D. b , Yunus Emre Bulut, M.D. c a b c
Palandoken State Hospital, Otorhinolaryngology Clinics, Erzurum, Turkey Ataturk University, Faculty of Medicine, Department of Otorhinolaryngology, Erzurum, Turkey Gaziosmanpasa University, Faculty of Medicine, Department of Public Health, Tokat, Turkey
ARTI CLE I NFO
A BS TRACT
Article history:
Purpose: We aimed to determine the effect of a cartilage shoe graft placed between the foot of
Received 26 October 2015
the TORP and the stapes footplate on hearing improvement and long-term displacement rates. Materials and methods: Patients who underwent TORP ossiculoplasty were divided into two groups. The TORP-alone group consisted of 32 patients who underwent TORP placement without cartilage shoe graft and served as the control group. The study group consisted of 56 patients who underwent placement of cartilage shoe graft together with TORP. Pure-tone audiometry was administered to all patients before and 3, 6 and 12 months after surgery. Indications for surgery, surgical technique used, postoperative complications, and air and bone conduction thresholds at 500, 1000, 2000 and 4000 Hz were recorded for all patients. Results: No significant difference in postoperative air–bone gaps was observed between the groups. The number of patients with air–bone gaps less than 20 dB was 14 (25%) in the study group and 8 (25%) in the control group. There was no significant difference in changes in air–bone gaps between the groups. Dislocation of the prosthesis was observed in 3 patients in the study group (5.3%) and 4 in the control group (12.5%). There was less dislocation of the prosthesis in the study group, but the difference was not statistically significant. Conclusion: Placement of a cartilage graft between the footplate of the stapes and the foot of the prosthesis may have positive effects on long-term hearing improvement and rates of prosthesis displacement. Further research with larger patient numbers is needed to identify the advantages of shoe graft. © 2016 Elsevier Inc. All rights reserved.
1.
Introduction
The human ossicular chain acts as a cantilever mechanism to permit reliable conduction of sound energy from the tympanic
☆
membrane to the oval window. An intact ossicular chain is required for successful hearing together with an intact, vibrating tympanic membrane and a ventilated middle ear. Defect in the ossicular chain is reconstructed using ossicular
All authors declare that there is no conflict of interest. The authors declare that they have nothing to disclose. ⁎ Corresponding author at: Palandoken State Hospital, Otorhinolaryngology Clinics, Erzurum, Turkey. Tel.: +90 5326564191. E-mail address: [email protected] (K. Kilic).
☆☆
http://dx.doi.org/10.1016/j.amjoto.2015.12.001 0196-0709/© 2016 Elsevier Inc. All rights reserved.
AMERI CA N JOURNAL OF OT OLAR YNGOLOGY–H E AD AN D N E CK M EDI CI N E AN D S U RGE RY 3 7 ( 2 0 16 ) 74–7 7
reconstruction prosthesis. There are two main types of prosthesis, partial ossicular reconstruction prosthesis (PORP) and total ossicular reconstruction prosthesis (TORP). The stapes superstructure is important in reconstruction choices. PORP is used in the presence of an appropriately oriented stapes superstructure. The superstructure provides a stable attachment point for the prosthesis. When the stapes superstructure is inappropriately oriented or damaged, TORP must be used. The ideal TORP must have similar acoustic characteristics and long-term stabilization to the human ossicular chain. In order to achieve successful hearing outcomes after ossiculoplasty, the prosthesis must be attached in a firm and stable manner. A loose connection results in inefficient energy transfer and a high risk of displacement. Prosthesis displacement is the second most important cause of ossiculoplasty failure, after persistence of middle ear disease [1]. A TORP consists of three main parts: a head in contact with the tympanic membrane, a thin shaft and a wider base of the shaft, the foot, which lies over the footplate. Either of these two connections may be the cause of displacement after surgery, resulting in a persistent postoperative air–bone gap. Several methods, intended to minimize the rate of ossicular displacement after reconstruction have been described. One consists of two-point fixations with cartilage grafting. Two-point fixation refers to fixation of the head of the prosthesis to the tympanoplasty graft and of the foot of the prosthesis to the footplate [2]. Establishing a stable TORPfootplate coupling is mandatory for successful reconstruction [3]. The purpose of this study was to determine the effect of a cartilage shoe graft on hearing improvement and long-term displacement rates. We prepared a cartilage shoe graft in order to achieve stable coupling between the foot of the TORP and the stapes footplate.
2.
Materials and methods
2.1.
Subjects
The study was performed at the Ataturk University Department of Otorhinolaryngology, Erzurum, between October 2013 and February 2015. All patients undergoing TORP ossiculoplasty were included. Patients with previous stapedectomy or stapedotomy or a history of aural atresia were excluded. Eighty-eight patients were included in the study. Age and gender, indications for surgery, surgical technique used, and postoperative complications were recorded for all patients. Patients were divided into two groups. The TORP-alone group consisted of 32 patients who underwent TORP placement without cartilage shoe graft and served as the control group. The study group consisted of 56 patients who underwent placement of cartilage shoe graft together with TORP. Pure-tone audiometry was administered to all patients before and 3, 6 and 12 months after surgery. Air and bone conduction thresholds were recorded at 500, 1000, 2000 and 4000 Hz. Pure-tone averages were calculated by averaging the thresholds for 500, 1000, 2000 and 4000 Hz for air and bone conduction. The air–bone gap was calculated for each patient as the difference between average air conduction and average bone conduction.
2.2.
75
Surgical technique
Under general anesthesia, all patients underwent type 3 tympanoplasty using a postauricular approach. Depending on the surgeon’s preference at the time of surgery, canal wall up or canal wall down procedures were employed. In the control group, a cartilage graft was formed from tragal cartilage and placed between the tympanoplasty graft and the head of the TORP as a “hat graft” and attached with bone cement. In the study group, as well as the hat graft, another piece of the cartilage was reshaped and placed between the foot of the TORP and the footplate as a “shoe graft” and attached with bone cement. In both groups, after preparation, the TORP was placed between the oval window and tympanic graft. The fascia of the temporal muscle was used for reconstruction of the tympanic membrane. All surgeries were performed by the same senior surgeon (E. A., with 20 years of experience).
2.3.
Statistical analysis
Statistical analyses were performed on SPSS 15.0 for Windows. The χ2 test was used to compare categorical variables, the t test for interval levels and analysis of variance when more than one independent variable was involved. Success of surgery is based on a postoperative air–bone gap of less than 20 dB. The rates of successful outcomes were compared between the groups using the χ2 test. P < 0.05 was considered statistically significant for all tests.
3.
Results
Eighty-eight patients were included in the study. The TORPalone group consisted of 32 patients (20 female, 12 male) and the study group of 56 (22 female, 34 male). Patients’ ages ranged from 12 to 68 with a median age of 34. There was no statistically significant difference in terms of age or gender between the groups. Patients’ demographic properties are summarized in Table 1. The main pathology was cholesteatoma, present in 28 patients in the study group (50%) and 18 in the control group (56.3%). Canal wall down procedures were performed in 24 patients from the study group (42.9%) and 14 from the control group (43.8%). There was no statistically significant difference in primary disease or surgical procedure between the groups (Table 1). According to the preoperative audiograms, there was no significant difference in preoperative air conduction, bone conduction or air–bone gap between the groups (Table 2). In
Table 1 – Comparison of the demographic properties of patients in study and control groups.
Average age Range of age Male/female Choleasteatoma CWD/CWU
Control (n = 32)
Study (n = 56)
35.7 18–60 12/20 18 14/18
33.1 12–68 34/22 28 24/32
p > 0.05 p > 0.05 p > 0.05 p > 0.05
76
AMERI CAN JOURNAL OF OTOLAR YNGOLOGY–H E AD AN D N E CK M EDI CI N E AN D S U RGE RY 3 7 ( 2 0 16 ) 74–7 7
Table 2 – Comparison of audiogram results of control and study groups.
Preoperative air conduction Preoperative bone conduction Preoperative air–bone gap Air–bone gap at postoperative 3rd month Air–bone gap at postoperative 6th month Air–bone gap at postoperative 12th month
Control
Study
69.3 18.5 50.7 31 29.3 29.9
69.7 19.1 50.5 33.6 31.5 29.9
the control group, there was a statistically significant difference between the preoperative air–bone gap and those at the 3rd, 6th and 12th month postoperatively. In addition, the air–bone gap at the postoperative 12th month differed significantly from that at the postoperative 3rd month. In the study group, the air– bone gaps at postoperative months 3, 6 and 12 differed significantly from the preoperative air–bone gap, as in the control group. Additionally, the air–bone gap at the postoperative 12th month differed significantly from that at the postoperative 3rd month. There was no significant difference in postoperative air–bone gaps between the groups (Table 2). TORP ossiculoplasty showed significant improvement in hearing. Table 3 showed the decibel gain and improvement in air–bone gap at postoperative 12th month. The number of patients with air–bone gaps less than 20 dB was 14 (25%) in the study group and 8 (25%) in the control group. Twenty-six patients (46.4%) in the study group and 14 (43.8%) in the control group had air–bone gaps less than 30 dB. There was no significant difference in changes in air–bone gaps between the groups. A second-look explorative tympanotomy was performed to the patients who had an unexpected recurrent air–bone gap within follow-up period. Dislocation of the prosthesis was diagnosed by this second-look approach. Dislocation of the prosthesis was observed in 3 patients in the study group (5.3%) and 4 in the control group (12.5%). There was less dislocation of the prosthesis in the study group, but the difference was not statistically significant (p = 0.025).
4.
Discussion
The aim of surgical treatment of chronic otitis media is to establish a healthy, ventilated middle ear and functional sound conduction mechanism. In patients with ossicular chain destruction, sound conduction can be achieved by ossicular chain reconstruction. This reconstruction can be performed by use of autologous incus or malleus grafts,
Table 3 – Comparison of preoperative and postoperative 12th month audiometric results of the patients.
Preoperative air conduction Postoperative air conduction Decibel gain Preoperative air–bone gap Postoperative air–bone gap Improvement in air–bone gap
Control
Study
69.3 52.8 16.5 50.7 29.9 20.8
69.7 50.8 18.9 50.5 29.9 20.6
± 12.3 ± 18.3 ± 9.6 ± 12.8
± 17.44 ± 18.6 ± 9.9 ± 11.3
± ± ± ± ± ±
12.3 10.8 9.6 12.3 13.1 12.8
± ± ± ± ± ±
17.44 13.9 9.9 12.8 11.2 11.3
p p p p p p
> > > > > >
0.05 0.05 0.05 0.05 0.05 0.05
including incus interpositioning [4]. However, in the absence of the malleus and incus, ossicular reconstruction prosthesis must be employed. The first middle ear prosthesis was introduced by Wullsteinin 1952 [4]. Several materials have subsequently been used for reconstruction of the ossicular chain, such as titanium, hydroxyapatite, plastipore and bone cement. The main requirements of a replacement material are biocompatibility and stability [2]. Bahmad et al. described the histopathology of ossicular implants and determined no foreign body reaction and inflammation in hydroxyapatite prostheses [5]. In recent years, titanium has become a favorite material for reconstruction due to its biocompatibility. Similarly, hydroxyapatite prostheses act like middle ear bones and do not cause osteogenic reaction. Studies comparing the use of hydroxyapatite and titanium prostheses have shown no difference in short- or long-term effectiveness between these two materials [6–8]. In our study, we used hydroxyapatite TORP for reconstruction of the ossicular chain. In patients with ossicular reconstruction, surgical success is defined as providing a postoperative air–bone gap less than 20 dB [2,4]. Since many other factors including primary disease, ventilation of the middle ear, and persistence of the disease may affect auditory outcomes after TORP ossiculoplasty, success rates after TORP ossiculoplasty in the literature differ. However, the general rate of success is between 25% and 60% [9–12]. In our study, 25% of the study group and 25% of the control group had postoperative air– bone gaps less than 20 dB. In addition, 46% of patients in the study group and 43% of patients in the control group had postoperative air–bone gaps less than 30 dB. The overall average hearing improvement was 18.4 dB (18.6 dB in the study group, 18.3 dB in the control group). Our results were similar to those published previously. The most important problem after ossiculoplasty is a persistent or recurrent air–bone gap, which mostly derives from persistence of the disease or displacement of the prosthesis [2]. Recent studies have focused on reducing the rate of prosthesis displacement after ossiculoplasty. Lateral stabilization of the prosthesis with a cartilage placed between the tympanic membrane and the prosthesis is a widely accepted method. Displacement rates have been reported to decrease to less than 2% with cartilage lateral stabilization [9,13–15]. However, it is also important to stabilize the prosthesis on the center of the footplate. Several methods have been introduced to fix the prosthesis to the footplate. Berenholz et al. used areolar tissue between the prosthesis shaft and footplate to avoid displacement and reported a postoperative air–bone gap less than 20 dB in 44% of patients [16]. Bremke et al. used a cartilage sandwich technique to stabilize the prosthesis over the footplate. They described
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their method as safe and reliable in ossiculoplasty [17]. Beutner et al. described a new technique for stabilization of the TORP at the center of the footplate, which they referred to as the cartilage shoe. In this technique, they placed a cartilage between the footplate and prosthesis to stabilize the TORP on the center of the footplate. They concluded that using the cartilage shoe may be beneficial in preventing TORP dislocation [3]. A titanium footplate shoe was used instead of cartilage in other studies. Fayad et al. reported better hearing results after ossiculoplasty with a titanium footplate shoe and TORP compared to TORP alone, but the difference was not statistically significant [4]. A similar shoe prosthesis was used by Cox et al., who also reported higher rates of success in patients treated with TORP+footplate shoe [2]. In our study, we used a cartilage shoe graft for stabilization of the prosthesis over the footplate in the experimental group. The hearing results in both groups were similar to those in previous studies. There was no difference in hearing outcomes between the groups. In addition, patients’ primary pathological findings and the surgical procedure performed did not affect the hearing results. At long-term follow-up, there was no decrease in sound conduction or air–bone gap at the postoperative 12th month. Less displacement of the prosthesis was observed in patients treated with TORP+shoe, but the difference was not statistically significant.
5.
Conclusion
Ossicular reconstruction remains a challenging problem. Although our study tended to favor the use of a cartilage graft placed between the footplate of the stapes and the foot of the prosthesis to have positive effects on long-term hearing improvement and rates of prosthesis displacement, the results were not statistically significant. Further research with larger patient numbers is needed to identify the advantages of shoe graft.
REFERENCES
[1] Yung M. Long-term results of ossiculoplasty: reasons for surgical failure. Otol Neurotol 2006;27(1):20–6.
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[2] Cox MD, Russell JS, Dornhoffer JL. TORP ossiculoplasty outcomes with and without a stapes footplate prosthesis. Otolaryngol Head Neck Surg 2015;152(3):501–5. http://dx.doi. org/10.1177/0194599814564538. [3] Beutner D, Luers JC, Huttenbrink KB. Cartilage 'shoe': a new technique for stabilisation of titanium total ossicular replacement prosthesis at centre of stapes footplate. J Laryngol Otol 2008;122(7):682–6. [4] Fayad JN, Ursick J, Brackmann DE, et al. Total ossiculoplasty: short- and long-term results using a titanium prosthesis with footplate shoe. Otol Neurotol 2014;35(1):108–13. [5] Bahmad Jr F, Merchant SN. Histopathology of ossicular grafts and implants in chronic otitis media. Ann Otol Rhinol Laryngol 2007;116(3):181–91. [6] Lee JI, Yoo SH, Lee CW, et al. Short-term hearing results using ossicular replacement prostheses of hydroxyapatite versus titanium. Eur Arch Otorhinolaryngol 2014;6 [Epub ahead of print]. [7] Truy E, Naiman AN, Pavillon C, et al. Hydroxyapatite versus titanium ossiculoplasty. Otol Neurotol 2007;28(4):492–8. [8] Yung M, Smith P. Titanium versus nontitaniumossicular prostheses-a randomized controlled study of the mediumterm outcome. Otol Neurotol 2010;31(5):752–8. [9] Slater PW, Rizer FM, Schuring AG, et al. Practical use of total and partial ossicular replacement prostheses in ossiculoplasty. Laryngoscope 1997;107(9):1193–8. [10] Murphy TP. Hearing results in pediatric patients with chronic otitis media after ossicular reconstruction with partial ossicular replacement prostheses and total ossicular replacement prostheses. Laryngoscope 2000;110(4):536–44. [11] Gardner EK, Jackson CG, Kaylie DM. Results with titanium ossicular reconstruction prostheses. Laryngoscope 2004; 114(1):65–70. [12] Ho SY, Battista RA, Wiet RJ. Early results with titanium ossicular implants. Otol Neurotol 2003;24(2):149–52. [13] Wang X, Song J, Wang H. Results of tympanoplasty with titanium prostheses. Otolaryngol Head Neck Surg 1999;121:606–9. [14] Kim HH, Wiet RJ. Preferred technique in ossiculoplasty. Oper Tech Otolaryngol Head Neck Surg 2003;14:243–6. [15] Mardassi A, Deveze A, Sanjuan M, et al. Titanium ossicular chain replacement prostheses: prognostic factors and preliminary functional results. Eur Ann Otorhinolaryngol Head Neck Dis 2011;128(2):53–8. [16] Berenholz L, Burkey J, Lippy W. Total ossiculoplasty: advantages of two-point stabilization technique. Int J Otolaryngol 2012;2012:346260. [17] Bremke M, Hüttenbrink KB, Beutner D. The sandwich cartilage shoe technique for ossicular reconstruction in a case of an unsecure stapes footplate. Laryngoscope 2011; 121(9):1950–2.