Objective: Among other difficulties, achieving a stable position of a total ossicular replacement prosthesis (TORP) is demanding because of a limited view on the TORP-footplate interface and individual angles between the footplate and tympanic membrane. The Kurz Omega Connector aims at a simplified insertion of the TORP. The performance of total ossicular reconstruction using the Omega Connector was evaluated.
Study design: Prospective cohort study and experimental measurements with a fresh human temporal bone.
Setting: Tertiary referral center.
Patients: Seventeen consecutive patients receiving total ossicular reconstruction were included. Historical control group composed of 36 patients.
Interventions: Total ossicular reconstruction using the Omega Connector.
Main outcome measures: (a) Handling of the TORP and Omega Connector intraoperatively, (b) functional short-term results compared with a historical control group, (c) sound transmission properties with 3 different connective positions between the TORP and the Omega Connector.
Results: Placing the Omega Connector on the footplate and coupling the Omega Connector to the TORP was straightforward in 65% of cases. A stable final position of the TORP was obtained in 88% of cases. Mean (SD) preoperative and postoperative air-bone gaps were 36.00 (11.05) and 25.29 (12.25) dB and were almost identical with those in the historical control group (p = 0.9). In the experimental measurements, functional outcomes with "partial connection" showed almost the same results as those with "full connection."
Conclusion: The Omega Connector provides easy handling of the TORP. The short-term functional results were comparable to those achieved previously without the Omega Connector. The temporal bone measurement supports tolerance in connective position between the TORP and the Omega Connector.