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result(s) for
"Ossicular Prosthesis"
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Autologous incus versus titanium partial ossicular replacement prosthesis in reconstruction of Austin type A ossicular defects: a prospective randomised clinical trial
2017
This study aimed to compare the functional and anatomical outcomes of ossiculoplasty using an autograft incus or a titanium partial ossicular replacement prosthesis for reconstructing Austin type A ossicular defects.
Patients with Austin A ossicular defects were randomly divided into two groups: one group underwent ossiculoplasty with an autologous incus (the autologous incus group) and the other underwent ossiculoplasty with a titanium partial ossicular replacement prosthesis (the titanium prosthesis group). Otoscopic examination and audiological assessment was done pre-operatively and at 3, 6 and 12 months post-operatively.
A post-operative average air-bone gap closure of less than 20 dB was seen in 13 patients (65 per cent) in the autologous incus group and 7 (35 per cent) in the titanium prosthesis group. There were fewer post-operative complications in the autologous incus group (20 per cent) than in the titanium prosthesis group (45 per cent).
Hearing outcomes and graft take up after ossiculoplasty were significantly better when an autologous incus rather than a titanium partial ossicular replacement prosthesis was used to reconstruct Austin type A ossicular defects. The major disadvantages of the titanium prosthesis were unpredictable results and more post-operative complications.
Journal Article
Safety and performance of the new med-el total ossicular replacement prostheses
2024
Purpose
This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP).
Methods
Patients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (for adverse events) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA
4
). The post-operative PTA
4
air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined.
Results
103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses.
Adverse events results (N = 102)
In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported.
Audiological results (N = 92)
49 (53.3%) of the 92 patients had a PTA
4
ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA
4
ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA
4
ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA
4
(post-operative minus pre-operative BC PTA
4
) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA
4
deterioration of 11.3 dB HL.
Conclusion
The MED-EL TORPs are safe and effective for middle ear reconstruction.
Trial registration number
NCT05565339, September 09, 2022, retrospectively registered.
Journal Article
Short-Term Hearing Prognosis of Ossiculoplasty in Pars Flaccida Cholesteatoma Using the EAONO/JOS Staging System
2019
OBJECTIVES: The aim of the present study was to investigate the prognostic factors for short-term hearing outcomes of ossiculoplasty for primary pars flaccida cholesteatoma according to the European Academy of Otology and Neurotology/Japanese Otological Society (EAONO/JOS) and 2015 JOS staging systems. MATERIALS and METHODS: A total of 34 patients with primary pars flaccida cholesteatoma who underwent one-stage tympanomastoidectomy with partial ossicular reconstruction using double cartilage block were included in the study. The postoperative pure-tone average air-bone gap (PTA-ABG) was calculated, and two criteria of successful hearing outcomes were defined as [less than or equal to]10 and [less than or equal to]20 dB. Patients were classified according to the EAONO/JOS and 2015 JOS staging systems. Cochran-Armitage test was used to statistically analyze staging, and Fisher's exact test was used to analyze other factors. RESULTS: Successful hearing outcome with postoperative PTA-ABG [less than or equal to]10 and [less than or equal to]20 dB occurred in 23.5% and 55.9% of cases, respectively. When postoperative PTA-ABG [less than or equal to]20 dB was defined as successful, the success rate significantly decreased with increase in EAONO/JOS stage, and S0 pathological status of the stapes (no involvement) was a significantly favorable predictive factor. When postoperative PTA-ABG [less than or equal to]10 dB was regarded as successful, the significantly favorable predictive factors were S0 pathological status of the stapes and development of mastoid cells with MC2-3 (better developed cells). CONCLUSION: Favorable prognostic factors for hearing outcomes of tympanomastoidectomy with partial ossicular reconstruction for primary pars flaccida cholesteatoma were low stage following the EAONO/JOS staging system and no stapes involvement and better development of mastoid cells following the 2015 JOS staging system. KEYWORDS: Cholesteatoma, tympanoplasty, prognosis, hearing
Journal Article
Clinical investigation of flat panel CT following middle ear reconstruction: a study of 107 patients
2014
Objectives
After middle ear reconstruction using partial or total ossicular replacement prostheses (PORP/TORP), an air–bone gap (ABG) may persist because of prosthesis displacement or malposition. So far, CT of the temporal bone has played the main role in the diagnosis of reasons for postoperative insufficient ABG improvement. Recent experimental and clinical studies have evaluated flat panel CT (fpCT) as an alternative imaging technique that provides images with high isovolumetric resolution, fewer metal-induced artefacts and lower irradiation doses.
Methods
One hundred and seven consecutive patients with chronic otitis media with or without cholesteatoma underwent reconstruction by PORP (
n
= 52) or TORP (
n
= 55). All subjects underwent preoperative and postoperative audiometric testing and postoperative fpCT.
Results
Statistical evaluation of all 107 patients as well as the sole sub-assembly groups (PORP or TORP) showed a highly significant correlation between hearing improvement and fpCT-determined prosthesis position. FpCT enables detailed postoperative information on patients with middle ear reconstruction.
Conclusions
FpCT is a new imaging technique that provides immediate feedback on surgical results after reconstructive middle ear surgery. Specific parameters evaluated by fpCT may serve as a predictive tool for estimated postoperative hearing improvement. Therefore this imaging technique is suitable for postoperative quality control in reconstructive middle ear surgery.
Key Points
•
Flat panel CT offers advantages with regard to artefacts and radiation dose
.
•
FpCT provides higher isovolumetric resolution of temporal bone and middle ear implants
.
•
FpCT allows prediction of the postoperative hearing outcome in patients
.
•
FpCT is an important tool for immediate postoperative quality control
.
•
FpCT improves postoperative management of patients with complications following ossicular replacement
Journal Article
Comparison of partial vs. total ossicular chain reconstruction using titanium prosthesis: a retrospective cohort study
by
Faramarzi, Ali
,
Roosta, Sareh
,
Faramarzi, Mohammad
in
Head and Neck Surgery
,
Medicine
,
Medicine & Public Health
2023
Purpose
Comparison of the hearing outcomes of titanium partial ossicular replacement prosthesis (PORP) vs. titanium total ossicular replacement prosthesis (TORP) with footplate shoe (Omega Connector) in second stage ossicular chain reconstruction surgeries.
Methods
In this retrospective cohort study in a tertiary hospital, we compared the hearing outcomes in 248 patients who had undergone ossicular chain reconstruction with titanium prostheses PORP (
n
= 115) vs. TORP (
n
= 133) from August 2017 to June 2021. Pre-and post-operative audiometric data were assessed.
Results
In general, we found that there were no significant differences between PORP and TORP groups in gains of BC (
P
= 0.080), AC (
P
= 0.454), ABG (
P
= 0.928), SRT (
P
= 0.065), and SDS (
P
= 0.363). There were no significant differences in terms of ABG gain between the two groups. Regarding ABG gains frequency-specific analysis in the ears with pre-operative conductive hearing loss, there were no significant differences between low-frequencies (
P
= 0.260) and high-frequencies (
P
= 0.973) between the two groups.
Conclusion
To sum up, this research provided additional evidence with respect to hearing outcomes after staged ossicular chain reconstruction with PORP and TORP. The practical application of our study is that TORP with footplate shoe (Omega Connector) is comparable with PORP in staged ossiculoplasty.
Journal Article
Feasibility of 3D-printed middle ear prostheses in partial ossicular chain reconstruction
2023
Despite advances in prosthesis materials, operating microscopes and surgical techniques during the last 50 years, long-lasting hearing improvement remains a challenge in ossicular chain reconstruction. Failures in the reconstruction are mainly due to inadequate length or shape of the prosthesis, or defects in the surgical procedure. 3D-printed middle ear prosthesis might offer a solution to individualize treatment and obtain better results. The aim of the study was to study the possibilities and limitations of 3D-printed middle ear prostheses. Design of the 3D-printed prosthesis was inspired by a commercial titanium partial ossicular replacement prosthesis. 3D models of different lengths (1.5-3.0 mm) were created with Solidworks 2019-2021 software. The prostheses were 3D-printed with vat photopolymerization using liquid photopolymer Clear V4. Accuracy and reproducibility of 3D printing were evaluated with micro-CT imaging. The acoustical performance of the prostheses was determined in cadaver temporal bones with laser Doppler vibrometry. In this paper, we present an outline of individualized middle ear prosthesis manufacturing. 3D printing accuracy was excellent when comparing dimensions of the 3D-printed prostheses and their 3D models. Reproducibility of 3D printing was good if the diameter of the prosthesis shaft was 0.6 mm. 3D-printed partial ossicular replacement prostheses were easy to manipulate during surgery even though they were a bit stiffer and less flexible than conventional titanium prostheses. Their acoustical performance was similar to that of a commercial titanium partial ossicular replacement prosthesis. It is possible to 3D print functional individualized middle ear prostheses made of liquid photopolymer with good accuracy and reproducibility. These prostheses are currently suitable for otosurgical training. Further research is needed to explore their usability in a clinical setting. In the future, 3D printing of individualized middle ear prostheses may provide better audiological outcomes for patients.
Journal Article
Efficacy of the active middle-ear implant in patients with sensorineural hearing loss
2013
This systematic review aims to advise on the effectiveness of the active middle-ear implant in patients with sensorineural hearing loss, compared with external hearing aids.
A systematic search of several electronic databases, including PubMed and Embase, was used to identify relevant studies for inclusion.
Fourteen comparative studies were included. Nine studies reported on the primary outcome of functional gain: one found that the middle-ear implant was significantly better than external hearing aids (p < 0.001), while another found that external hearing aids were generally significantly better than middle-ear implants (p < 0.05). Six of the seven remaining studies found that middle-ear implants were better than external hearing aids, although generally no clinically significant difference (i.e. ≥ 10 dB) was seen.
Generally, the active middle-ear implant appears to be as effective as the external hearing aid in improving hearing outcomes in patients with sensorineural hearing loss.
Journal Article
A Comparative Study of Ossicular Reconstruction with TORP/PORP Versus Autologous Bone in Middle Ear Surgeries
by
Yathati, Kireet
,
Telang, Rahul Ashok
,
Sanap, Ravi Shriram
in
Age groups
,
Audiometry
,
Cartilage
2024
Chronic otitis media causes considerable morbidity in the form of hearing disability to the patient. Otologists aim to achieve through their surgery a near normal neo-membrane with continuous ossicular chain and a postoperative middle ear status which functionally bears close resemblance to the normal state. The objective of this study is to compare ossicular reconstruction with TORP/PORP versus autologous bone and compare the air–bone gap before and after surgery. This study was done at a tertiary care referral center. Eighty patients of chronic otitis media were divided into two groups and patients underwent cortical mastoidectomy with ossicular reconstruction in the form of TORP/PORP in one group and autologous bone in another. In the TORP/PORP group, the mean preoperative air–bone gap was 45.4 dB which was reduced to a mean air–bone gap of 19.45 dB. In the bone ossiculoplasty group, the mean preoperative air–bone gap was 43.38 dB which was reduced to a mean air–bone gap of 21.84 dB postoperatively. This study indicated that patients who underwent reconstruction with TORP/PORP had better improvement than those who received autologous bone. The results were statistically significant. Two cases who received TORP/PORP had extrusion due to infection. The patients were followed up till 1 year postsurgery.
Journal Article
Exclusive endoscopic ossiculoplasty with autologous material: step-by-step procedure and functional results
2023
Purpose
To describe the surgical procedure of exclusive endoscopic ossiculoplasty (EEO) with autologous grafts and evaluate audiological results, focusing on the advantages or drawbacks compared to the corresponding microscopic technique.
Methods
A retrospective review of consecutive adult and pediatric patients affected by chronic otitis media (COM) with or without cholesteatoma who underwent EEO was conducted. Only autologous ossiculoplasty was included in the study. The procedure was performed by experienced surgeons of our institution between November 2014 and September 2019. Hearing outcomes were evaluated using postoperative air–bone gap (ABG) and success rates in different subgroups of patients and different types of ossiculoplasty (OPL) were analyzed. Our results were finally compared with the existing literature regarding both microscopic and endoscopic ossicular chain reconstruction.
Results
In total, 74 endoscopic ossicular chain repair procedures performed within the study period met the inclusion criteria. Of these, 21 were pediatric patients (28%) and 53 were adults (72%). Surgical reconstruction procedures included 43 partial ossicular reconstructions (POR) and 31 total ossicular reconstructions (TOR). The postoperative ABG improved significantly compared to preoperative measurements, and the mean ABG closure was 7.85 dB HL (
p
= 0.00064). No statistically significant differences in audiological outcomes between TOR/POR techniques and pediatric/adult groups were found in our study cohort, with
p
values of 0.10 and 0.88, respectively.
Conclusions
At present, EEO can be considered a valid surgical option for re-establishing a functioning ossicular chain with acceptable hearing restoration in children and adults. Further reports in wider case series are required to confirm these results.
Journal Article
Ossiculoplasty outcome parameter staging index as a prognostic factor in ossiculoplasty
by
Ahmed, Aftab
,
Khan, Danish
,
Sharma, Satish
in
Medical prognosis
,
Medical research
,
Medicine, Experimental
2022
Aims: To evaluate the prognostic value of Ossiculoplasty Outcome Parameter Staging (OOPS) index with reference to the audiological outcome in the patients undergoing ossiculoplasty. Study Design: A prospective study. Setting: A tertiary referral hospital. Subjects: The study comprised 118 patients suffering from chronic otitis media with or without cholesteatoma. Materials and Methods: Ossiculoplasty was done by autologous incus interposition, partial ossicular prosthesis, and total ossicular prosthesis. Temporalis fascia graft was used for myringoplasty in all the patients. When partial ossicular replacement prosthesis or total ossicular replacement prosthesis was used a thin slice of cartilage was interposed between graft and prosthesis. The mastoidectomy was performed when needed, and whenever possible, a canal wall-up procedure was performed. Results: The short-term (measured after 3 and 6 months of surgery) and long-term (measured at 1 and 2 years after surgery) outcome of ossiculoplasty measured as a relationship between mean audiological gain and OOPS index score had a statically significant difference. Conclusion: The OOPS index is an appropriate prognostication index to predict accurately both the short- and long-term outcome of ossiculoplasty.
Journal Article