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Published on: October 16, 2021
Short-term safety and effectiveness of the mCLIP partial prosthesis
Thomas Rasse1, Lisa Niederwanger1, Joachim Hornung2
1Department of Otorhinolaryngology, Klinikum Wels-Grieskirchen, 4600, Wels, Austria.
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.
Insights
The mCLIP Partial Prosthesis demonstrated good short-term safety and effectiveness in tympanoplasty patients. Audiological outcomes were satisfactory, with most patients achieving an air bone gap of 20 dB or less.
Area of Science:
- Otolaryngology
- Medical Devices
- Surgical Outcomes
Background:
- Retrospective analysis of mCLIP Partial Prosthesis implantation.
- Clinical trial registration: NCT05565339, registered September 9, 2022.
- Study focused on short-term safety and effectiveness.
Purpose of the Study:
- To evaluate the short-term safety and effectiveness of the mCLIP Partial Prosthesis in tympanoplasty.
- To analyze audiological outcomes and adverse events following prosthesis implantation.
Main Methods:
- Multicentric retrospective study involving patients undergoing tympanoplasty with mCLIP Partial Prosthesis.
- Post-operative assessment included ear microscopy and pure-tone audiometry (PTA4).
- Audiological outcome evaluated by post-operative PTA4 air bone gap (ABG); adverse events (AE) were recorded.
Main Results:
- 72 patients (66 adults, 6 children) received the prosthesis.
- 72.1% of patients achieved a PTA4 ABG ≤ 20 dB; bone conduction thresholds were stable in 67 patients.
- 15 patients (20.8%) experienced adverse events; mean follow-up was 78 days for audiological analysis and 375 days for AE.
Conclusions:
- The mCLIP Partial Prosthesis shows satisfactory audiological parameters post-implantation.
- The prosthesis is deemed safe and effective for both adult and pediatric tympanoplasty patients.
