European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
Safety and performance of the new med-el total ossicular replacement prostheses.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Schimanski Esther, Lenarz Thomas, Busch Susan, Arndt Susan, Offergeld Christian, Arnoldner Christoph, Riss Dominik, Hornung Joachim, Taha Lava, Zwittag Paul Martin, Rubicz Nina, Beutner Dirk, Bevis Nicholas, Loader Benjamin, Windisch Franz, Sprinzl Georg, Magele Astrid, Wolfram Wendelin, Niederwanger Lisa, Plichta Łukasz, Skarżyński Piotr H
Аннотация
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 (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.
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 PTA4 ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA4 ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA4 ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA4 (post-operative minus pre-operative BC PTA4) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA4 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.
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 (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.
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 PTA4 ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA4 ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA4 ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA4 (post-operative minus pre-operative BC PTA4) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA4 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.