|Year : 2017 | Volume
| Issue : 1 | Page : 36-42
To study the results of àWengen titanium clip piston prosthesis in stapedotomy
Raman Wadhera, Madhuri Kaintura, Sharad Hernot, Sandeep Bhukar, S Dheeraj, Usha Sehrawat, Jitu Sam George
Department of Otorhinolaryngology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, India
|Date of Web Publication||6-Feb-2017|
Dr. Sharad Hernot
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak - 124 001, Haryana
Source of Support: None, Conflict of Interest: None
Objective: To study the hearing results in patients implanted with àWengen titanium clip piston prosthesis after stapedotomy. Methods: In this prospective study, 15 patients of either sex in the age group of 18–50 years having conductive hearing loss with an air-bone gap (ABG) of 30 dB or more, with an intact tympanic membrane, and A or As type of curve in tympanometry were recruited. All patients underwent stapedotomy using àWengen titanium clip piston (Kurz, Germany) which was designed to avoid the scrupulous task of crimping a piston onto the long process of incus. The results were tabulated in accordance with the guidelines set by the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery (1994) at frequencies of 0.5, 1, 2 and 3 kHz. The follow-up period was 3 months. Results: The mean preoperative bone conduction (BC) was 16.00 ± 6.02 dB, at 6 weeks postoperative was 16.58 ± 12.40 dB, and at 3 months was 16.00 ± 10.80 dB. The mean preoperative ABG was 42 ± 7.26 dB, at 6 weeks postoperative was 20.5 ± 9.77 dB, and at 3 months was 17.25 ± 10.59 dB. There was improvement in postoperative BC, as well as ABG in 14 patients (except one). Conclusion: The use of the àWengen titanium clip stapes piston gives good results in cases of stapedotomy for otosclerosis. It is easy to insert onto the long process of incus and evades the complex step of crimping. The gain in hearing post surgery is comparable with the other types of pistons reported in literature.
Keywords: àWengen titanium clip stapes piston, otosclerosis, stapedotomy
|How to cite this article:|
Wadhera R, Kaintura M, Hernot S, Bhukar S, Dheeraj S, Sehrawat U, George JS. To study the results of àWengen titanium clip piston prosthesis in stapedotomy. Indian J Otol 2017;23:36-42
|How to cite this URL:|
Wadhera R, Kaintura M, Hernot S, Bhukar S, Dheeraj S, Sehrawat U, George JS. To study the results of àWengen titanium clip piston prosthesis in stapedotomy. Indian J Otol [serial online] 2017 [cited 2021 Feb 25];23:36-42. Available from: https://www.indianjotol.org/text.asp?2017/23/1/36/199507
| Introduction|| |
Otosclerosis or otospongiosis is a hereditary disease characterized by degeneration of the otic capsule, focal bone neoformation, and increased local vascularization. The British National Study of Hearing has defined presumptive clinical otosclerosis as an ear where the tympanic membrane is normal, the tympanogram is peaked with normal pressure range, and there is an associated air-bone gap (ABG) of 15 dB or greater over 0.5, 1, and 2 kHz.
The main clinical symptom described by patients is hearing loss, followed by tinnitus. This disease affects between 0.5% and 1.0% of the world's population and presents bilateral involvement in 70%–85% of the cases. Prevalence rates are higher among females and subjects in their thirties and forties. The most frequently affected region of the otic capsule is the area around the oval window and the footplate of the stapes. The disease leads to the fixation of the stapes and consequently compromises the function of the ossicular chain even when the malleus and the incus are normal. This is why conductive hearing loss is more common in otosclerosis although mixed or sensorineural cases may also be observed, particularly in cases of extensive disease or cochlear otosclerosis. The malleus and incus are rarely involved.,
Over the years, many modifications of the surgical technique have constantly refined stapes surgery. Apart from the changes in surgical technique, the prostheses themselves have undergone considerable modifications. Prostheses currently used in stapes surgery differ in the form of diameter of the piston, length of the implant, and also in weight. At present, there is a wide array of materials from which the prostheses are made such as Teflon, steel, gold, nitinol, and titanium. Titanium was first used in ossicular repair in Germany in 1993. Its advantages include significant tensile strength and low weight. They do not pose hazard when exposed to the high-intensity magnetic fields of magnetic resonance imaging examination up to 1.5 T. The reason for its excellent biocompatibility is the formation of a superficial layer of TiO2, with a very low rate of solvability. Its high ratio of resistance/weight and its practical lack of toxicity make titanium very eligible for implantation. Titanium devices are also light with weights close to the human stapes of about 2.8 mg. This improves outcome in high frequencies and discrimination. Daniel àWengen together with Kurz Medizintechnik (Dusslingen, Germany) developed a novel prosthesis made of titanium [Figure 1]; this prosthesis no longer has to be crimped but is held in place on the long process of the incus by means of a specially designed clip. It retains its position on the long process as a result of shape memory of titanium. The clip does not completely encircle the long process of the incus but covers it only for about 60% of its circumference. This should promise less risk of strangulation of the long process of the incus, which in turn reduces the likelihood of bone necrosis. According to àWengen, further advantages are the reduced time taken for surgery, thanks to the easier application of the prosthesis, and better acoustic coupling because of the stable fixation of the head of the prosthesis.
| Methods|| |
The present prospective study has been conducted in the Department of Otorhinolaryngology, Pt. B.D. Sharma PGIMS, Rohtak.
This study has been conducted on 15 patients.
- Between the ages of 18 and 50 years
- Having conductive hearing loss with an intact tympanic membrane [Figure 2]
- With an ABG of 30 dB or more
- With A or As type of curve in tympanometry.
|Figure 2: Preoperative pure tone audiogram showing bilateral conductive hearing loss.|
Click here to view
- Patients having sensorineural hearing impairment
- Less than 30 dB ABG on pure tone audiometry (PTA)
- Mixed hearing loss
- History of any previous ear surgery
- History of chronic suppurative otitis media
- History of trauma
- B or C or Ad type of curve on tympanometry.
All patients were assessed thoroughly before surgery. A written informed consent was taken from the patients explaining the advantages, disadvantages, and complications of the treatment being offered and about being included in the present study. Detailed history was taken including symptoms of hearing loss, tinnitus, vertigo, or any associated complaint. Family history consisting of similar complaints in parents or siblings was also taken. History of trauma, previous ear surgery, and any history of ear discharge was taken. Otoscopic examination and tuning fork tests were done. PTA and impedance audiometry were done in all the patients. PTA was performed for frequencies ranging between 0.5 and 8 kHz for air conduction and between 0.5 and 4 kHz for bone conduction (BC) including the frequency band of 3 kHz.
Steps of surgery
The patient was prepared and draped like any ear case. Steps for a routine stapedotomy were followed. The footplate was examined for the Portman type. The otosclerotic lesions found during surgery were classified according to Portman as Type 1: normal aspect (ankylosis of annular ligament); Type 2: focus involves the anterior quarter of the footplate; Type 3: focus involves more than anterior half of the footplate; Type 4: focus involves entire footplate; Type 5: complete obliteration of the footplate., A hole was made in the stapes footplate using hand burr [Figure 3]. A 0.6 mm × 4.5 mm diameter W clip titanium piston was placed in the fenestrum and then slipped onto the long process of incus [Figure 4]. The tympanomeatal flap was repositioned, and the hearing was checked on table. There was improvement in all cases. Postoperatively, intravenous antibiotic (amoxicillin + clavulanic acid) was given on the day of surgery. Patients were discharged the next day on oral antibiotics and painkillers. They were advised to avoid forceful blowing of the nose, to sneeze with mouth open, and to avoid lifting heavy weights.
The first follow-up was done after 1 week and mastoid dressing was removed. The second follow-up was done at 6 weeks and PTA was done. The third follow-up was done at 3 months and PTA was done [Figure 5].
|Figure 5: Three months postoperative pure tone audiogram showing improvement in hearing of left ear after stapedotomy.|
Click here to view
The hearing results were categorized into four groups:
- Subjects with an average postoperative ABG of 10 dB and under (reflecting excellent surgical outcome)
- Subjects with an average postoperative ABG between 11 and 20 dB (reflecting good surgical outcome)
- Subjects with an average postoperative ABG between 21 and 30 dB (reflecting satisfactory surgical outcome)
- Subjects with an average postoperative ABG >30 dB (poor outcome stapedotomy).
The results tabulated in accordance with the guidelines set by the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery (1994). The results were analyzed at frequencies of 0.5, 1, 2, and 3 kHz. At the end of the study, the data were collected and analyzed statistically using Student's t-test (paired). A P < 0.05 was considered as statistically significant.
| Results|| |
The patients were divided into two groups:
- <40 years: 12 patients
- >40 years: 3 patients.
The average preoperative ABG in <40 years age group at baseline was 41.77 ± 4.50 dB which decreased significantly postoperatively after 6 weeks to 20.20 ± 7.14 dB and subsequently to 15.41 ± 5.52 dB at 3 months.
However, in >40 years age group, average preoperative ABG was 42.91 ± 7.63 dB which decreased to 21.66 ± 13.24 dB at 6 weeks and 24.58 ± 20.20 dB at 3 months [Table 1] and [Figure 6].
|Figure 6: Average air-bone gap in dB preoperatively, postoperatively at 6 weeks, and postoperatively at 3 months: distribution according to age.|
Click here to view
The results were insignificant statistically when compared for age.
Our study comprised 8 females (53.33%) and 7 males (46.66%).
Unilateral versus bilateral of hearing loss
More number of patients had bilateral symptoms, i.e., 12 (80%). Only three patients had unilateral hearing loss (20%).
Right ear was operated in eight patients (53.33%) and left ear was operated in seven patients (46.66%).
Duration of symptoms
On basis of duration of symptoms, we divided our patients into four groups:
- Up to 1 year: 4 patients
- 1–5 year: 7 patients
- 5–10 year: 3 patients
- >10 year: 1 patient.
Preoperative ABG in age <1 year was 38.23 ± 3.88 dB, 6 weeks postoperative ABG was 23.12 ± 8.80 dB (P< 0.05), and 3 months postoperative ABG was 17.81 ± 7.99 dB (P < 0.05). Preoperative ABG in 1–5 years duration was 43.21 ± 4.07 dB, which decreased significantly to 18.21 ± 7.02 dB and 12.85 ± 4.25 dB at 6 weeks and 3 months interval, respectively (P < 0.05). Further, in 5–10 years duration group, a mean ABG of 46.25 ± 4.50 dB was observed preoperatively, 17.91 ± 8.02 at 6 weeks postoperatively, and 17.08 ± 6.16 at 3 months postoperatively, which also showed significant decrease (P < 0.05). In more than 10 years duration, data could not be calculated as the number of patient was 1 [Table 2] and [Figure 7].
|Figure 7: Average air-bone gap in dB preoperatively, at 6 weeks postoperatively, and at 3 months postoperatively according to the duration of hearing loss.|
Click here to view
Nine patients had Portman grade Type 4 (60%) and six patients had Grade 3 (40%). None of the patients had Grade 1, 2, or 5. The average ABG in Type 3 patients was 39.79 ± 3.39 dB preoperatively, and 24.16 ± 9.37 dB at 6 weeks postoperatively, and 20.41 ± 13.63 dB at 3 months postoperatively, with significant improvement (P < 0.05). In addition, patients who had Type 4 Portman grade showed a mean ABG of 43.47 ± 5.44 dB preoperatively, 18.05 ± 6.55 dB at 6 weeks postoperatively, and 15.13 ± 6.35 dB at 3 months postoperatively, which was statistically highly significant (P < 0.001) [Table 3] and [Figure 8].
|Figure 8: Average air-bone gap in dB preoperatively and postoperatively (6 weeks and 3 months) according to Portman grade.|
Click here to view
Bilateral “A” type was found in 12 patients (80%). Only three patients had bilateral “As” type.
Comparison of preoperative and postop bone conduction at 6 weeks and 3 months
Preoperative BC at various frequencies, i.e., 0.5, 1, 2, and 3 kHz was 14.66 ± 4.80 dB,15 ± 3.77 dB, 18.66 ± 6.93 dB, and 15.66 ± 7.52 dB, respectively. Total preoperative mean BC was 16.00 ± 6.02 dB.
The postoperative BC at 6 weeks at various frequencies, i.e., 0.5, 1, 2, and 3 kHz was 15.33 ± 10.60 dB, 16.66 ± 13.04 dB, 12 ± 12.07 dB, and 16.33 ± 14.69 dB, respectively. Total postoperative mean BC at 6 weeks was 16.58 ± 12.40 dB.
No significant difference in preoperative and postoperative values was noted and it was found to be almost comparable at all stages (P > 0.05). Out of 15 patients, 14 showed mild improvement.
Postoperative BC at 3 months at frequencies of 0.5, 1, 2, and 3 kHz with a mean of 15.66 ± 10.83 dB, 15.66 ± 11.62 dB, 16.66 ± 9.94 dB, and 16 ± 11.83 dB, respectively. Total postoperative mean BC was 16 ± 10.80 dB. No significant difference at preoperative and postoperative values was noted, and it was found to be almost comparable at all stages (P > 0.05). One patient out of 15 had sensorineural hearing loss which leads to an increase in average postoperative BC; otherwise, rest of 14 patients had mild improvement in BC postoperatively as compared to the preoperative value [Figure 9].
|Figure 9: Mean bone conduction at preoperative and postoperative (6 weeks and 3 months).|
Click here to view
Comparison of preoperative and postop air-bone gap at 6 weeks and 3 months
The mean ABG at various frequencies, i.e., 0.5, 1, 2, and 3 kHz was 43.33 ± 7.48 dB, 44 ± 7.12 dB, 36.66 ± 6.46 dB, and 44 ± 5.73 dB, respectively. Total preoperative mean ABG for all frequencies was 42 ± 7.26 dB, with a range of 30–65 and median 40 dB.
The postoperative ABG at 6 weeks at various frequencies, i.e., 0.5, 1, 2, and 3 kHz was 20.66 ± 8.42 dB, 21.33 ± 9.53 dB, 18.33 ± 10.80 dB, and 21.66 ± 10.80 dB, respectively.
The average mean was 20.5 ± 9.77 dB in all frequencies, with a range of 5–45 and median 20 dB.
ABG had decreased significantly after 6 weeks at all frequencies and was found to be highly significant (P < 0.001).
Mean postoperative ABG at 3 months was 18.33 ± 10.96 dB at 500 Hz, 20 ± 11.18 dB at 1 kHz, 14.33 ± 10.83 dB at 2 kHz, and 16.33 ± 9.53 dB at 3 kHz. The average total mean was 17.25 ± 10.59 dB, with a range of 5–50 and median 15 dB.
ABG decreased significantly after 3 months at all frequencies and was found to be highly significant (P < 0.001) [Figure 10].
|Figure 10: Mean air-bone gap at preoperative and postoperative (6 weeks and 3 months).|
Click here to view
The patients were divided according to postoperative ABG at 3 months and categorized into excellent, good, satisfactory, and poor.
In the present study, four patients had excellent outcome with ABG <10 dB (28.57%).
Nine patients had good outcome with postoperative ABG between 11 and 20 dB (63.28%). Hence, in 13 patients, the postoperative ABG was <20 dB (86.67%).
One patient had satisfactory outcome with an ABG of 23.75 dB [Table 4].
One patient had sensorineural hearing loss and therefore could not be included in the above classification.
| Discussion|| |
The mean age in our study is lower than most studies. The female to male ratio is also less which may be due to the fact that the outpatient department in our hospital mainly comprises the rural population where the medical needs of a female tend to be overlooked as compared to males. In our study, results were slightly better in the age group <40 years, but they were statistically insignificant.
In the present study, distribution of patients according to Portman grading was done.
The reason for increased percentage of a higher Portman grade in our study is probably due to delay in seeking medical attention for hearing loss alone (i.e., without the troublesome discharge) in a developing country like ours where the general population belongs to a lower socioeconomic status.
The mean preoperative BC was 16.00 ± 6.02 dB, at 6 weeks postoperative was 16.58 ± 12.40 dB, and at 3 months was 16.00 ± 10.80 dB. There was improvement in postoperative BC in all the patients, except 1 (in which there was sensorineural hearing loss), leading to a small increase in the overall mean postoperative BC, which was statistically insignificant.
The results of the present study were comparable to that of the literature.
The mean preoperative ABG was 42 ± 7.26 dB, at 6 weeks postoperative was 20.5 ± 9.77 dB, and at 3 months was 17.25 ± 10.59 dB.
Overall, our results were analogous to that given in the literature.
Four patients had excellent outcome with ABG <10 dB (28.57%). Nine patients had good outcome with postoperative ABG between 11 and 20 dB (63.28). Hence, in 13 patients, the postoperative ABG was <20 dB (86.67%). One patient had satisfactory outcome with an ABG of 23.75 dB (clinically, however, the patient had no problems in listening to normal conversation and was satisfied with the improvement).
One patient had sensorineural hearing loss and therefore could not be included in the above classification and was regarded as a failure.
One patient had cerebrospinal fluid gusher, but the prosthesis was not implanted in her and thus the patient was excluded from the study. However, the patient did not develop any sensorineural hearing loss postoperatively.
| Conclusion|| |
W clip piston introduced by àWengen is easy to insert onto the long process of incus and evades the complex step of crimping. We did not encounter any problem in inserting this piston as opposed to that stated by Shimanski et al., who felt the need to modify this piston because they found it hard to adapt to the different diameters of the long process of incus.
We advocate that the piston can be held easily by its knob using microcup forceps or suction tip.
Should the piston fall in the hypotympanum, suction tip is very useful for retrieving it rather than a forceps as this may deform the delicate piston.
We also recommend packing the hypotympanum with cotton pellets to avoid losing the piston from view in case it slips accidently.
The only factor not in favor of this piston is its cost.
The gain in hearing postsurgery is comparable with the other types of piston reported in literature.
However, a longer follow-up is required to establish its long-term effect on hearing.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Browning GG, Gatehouse S. The prevalence of middle ear disease in the adult British population. Clin Otolaryngol Allied Sci 1992;17:317-21.
Schwager K. Titanium as an ossicular replacement material: Results after 336 days of implantation in the rabbit. Am J Otol 1998;19:569-73.
Beales PH. Otosclerosis. In: Booth JB, editor. Scott-Brown's Otorhinolaryngology, Head and Neck Surgery. 5th
ed. London: Butterworth; 1987. p. 319.
Kwok P, Fisch U, Strutz J, Jacob P. Comparative electron microscopic study of the surface structure of gold, Teflon, and titanium stapes prostheses. Otol Neurotol 2001;22:608-13.
Hornung JA, Brase C, Bozzato A, Zenk J, Iro H. First experience with a new titanium clip stapes prosthesis and a comparison with the earlier model used in stapes surgery. Laryngoscope 2009;119:2421-7.
Gardner EK, Jackson CG, Kaylie DM. Results with titanium ossicular reconstruction prostheses. Laryngoscope 2004;114:65-70.
Dalchow CV, Grün D, Stupp HF. Reconstruction of the ossicular chain with titanium implants. Otolaryngol Head Neck Surg 2001;125:628-30.
Ataide AL, Bichinho GL, Patruni TM. Audiometric evaluation after stapedotomy with Fisch titanium prosthesis. Braz J Otorhinolaryngol 2013;79:325-35.
Chiselita L, Cotulbea S, Raica M, Marin AH, Honoiu B, Balica N. Experimental study regarding the biocompatibility of titanium with the histological structures of the middle ear. Rev Rom ORL 2008;31:114-9.
Tange RA, Grolman W, Dreschler WA. Gold and titanium in the oval window: A comparison of two metal stapes prostheses. Otol Neurotol 2004;25:102-5.
Wengen DF. A new self-retaining titanium clip stapes prosthesis. Adv Otorhinolaryngol 2007;65:184-9.
Tange RA, Grolman W. An analysis of the air-bone gap closure obtained by a crimping and a non-crimping titanium stapes prosthesis in otosclerosis. Auris Nasus Larynx 2008;35:181-4.
Portmann M, Guerrier Y. Traite de technique chirurgicale ORL et cervico-faciale. In: Tome Premier Oreille et Os Temporale. Paris: Masson and Cie; 1975. p. 108-9.
[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10]
[Table 1], [Table 2], [Table 3], [Table 4]