Short-term safety and effectiveness of the mCLIP partial prosthesis.

PURPOSE: This multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP Partial Prosthesis. METHODS: Patients underwent tympanoplasty with implantation of a mCLIP Partial Prosthesis. Follow-up examination included ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Thus, the follow-up times of each study center were different, which resulted in different follow-up times for the audiological analysis and for adverse events (AE). RESULTS: 72 (66 adults, 6 children) patients were implanted with the mCLIP Partial Prosthesis. 68 (62 adults, 6 children) patients underwent audiological examination; all 72 patients were examined for adverse events. All patients (N = 68): 72.1% of the patients showed a PTA4 ABG of ≤ 20 dB. Individual post-operative bone conduction (BC) PTA4 thresholds were stable in 67 patients. The mean post-operative follow-up time was 78 ± 46 days. Children (N = 6): 5 out of 6 children showed a PTA4 ABG of ≤ 20 dB. None of the children reported a BC PTA4 deterioration of > 10 dB HL after the implantation. The mean post-operative follow-up time was 101 ± 45 days. Adverse events (all patients, N = 72): 15 (14 adults, 1 child) patients had AEs (27 AEs and 2 Follow-Ups). The mean post-operative follow-up time was 375 days. CONCLUSION: Clinical data show satisfactory audiological parameters after implantation of the mCLIP Partial Prosthesis. The prosthesis is safe and effective for implantation in children and adults. TRIAL REGISTRATION NUMBER: NCT05565339, 09 September 2022, retrospectively registered.

Diagnostic findings in stapes revision surgery--a retrospective of 26 years.

OBJECTIVE: The aim of the study is to obtain a detailed overview of the revision findings after stapes operations and to draw conclusions on a stapes prosthesis that can be recommended. STUDY DESIGN: : Retrospective case series. SETTING: Tertiary otologic referral center. METHODS: Approximately 12,000 middle ear operations within a period of 26 years were evaluated. The findings of the revisions were classified into surgeon related, prosthesis related, and other causes. RESULTS: Three hundred forty-three stapes revisions were done. Many different prostheses were found: the most common were Schuknecht prostheses and Teflon platinum, gold, and titanium pistons. Polyethylene strut, Teflon wire pistons, Shea (Teflon) pistons, and other techniques, such as columella or malleovestibulopexy, were rarely found.There are specific findings correlating to certain prostheses: Schuknecht prostheses were too short in 50% of the revisions (surgeon related), Teflon platinum caused necrosis or arrosion of the long incudal process (prostheses related) in 69%, and gold caused reparative granuloma sometimes combined with necosis of the incus in 70% (prostheses related). There was no specific diagnostic finding with titanium pistons, neither surgeon nor material related. CONCLUSION: An analysis of revision findings over an extended observation period can enable middle-ear surgeons to improve their surgical techniques and to select the best suited prosthesis. Self-fabricated stapes prostheses (e.g., Schuknecht) do not conform to required quality standards and should not be used. GoPi, which is no longer available, and TPlPi showed prosthesis-related diagnostic findings. The titanium prostheses used by the authors have proven to be excellently compatible and can therefore be recommended as safe stapes prostheses.