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CLINICAL TRIAL
COMPARATIVE STUDY
CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
Bone cement reconstruction of the ossicular chain: a preliminary report.
Laryngoscope 1998 June
OBJECTIVE: To determine the feasibility and efficacy of using a bone cement, Oto-Cem, to reconstruct the ossicular chain.
STUDY DESIGN: Prospective clinical trial on nine consecutively chosen adult patients with ossicular chain defects.
PATIENTS AND SETTING: Nine patients with ossicular chain defects involving the long process of the incus were treated at the Carolina Ear and Hearing Clinic. The ossicular chain was reconstructed using bone cement by itself or in conjunction with a stapes prosthesis.
MAIN OUTCOME MEASURES: Preoperative audiograms were compared with audiograms 3, 6, and 12 months after reconstruction.
RESULTS: There was a mean pure-tone average (PTA) improvement of 15 dB in patients undergoing incus to stapes suprastructure reconstruction with the bone cement. The incus to mobile footplate reconstruction (using a stapes prosthesis attached to the newly reconstructed incus) resulted in a 34-dB PTA postoperative improvement. Two of the three patients with incus to oval window repairs experienced a 10-dB improvement in PTA. One of the three patients experienced a loss in speech discrimination and a 2-dB loss in PTA.
CONCLUSIONS: Despite the limited number of patients, this preliminary study demonstrates the effectiveness of Oto-Cem in reconstructing a foreshortened incus. There was a substantial hearing improvement in all but one patient in the incus to stapes or the incus to footplate categories.
STUDY DESIGN: Prospective clinical trial on nine consecutively chosen adult patients with ossicular chain defects.
PATIENTS AND SETTING: Nine patients with ossicular chain defects involving the long process of the incus were treated at the Carolina Ear and Hearing Clinic. The ossicular chain was reconstructed using bone cement by itself or in conjunction with a stapes prosthesis.
MAIN OUTCOME MEASURES: Preoperative audiograms were compared with audiograms 3, 6, and 12 months after reconstruction.
RESULTS: There was a mean pure-tone average (PTA) improvement of 15 dB in patients undergoing incus to stapes suprastructure reconstruction with the bone cement. The incus to mobile footplate reconstruction (using a stapes prosthesis attached to the newly reconstructed incus) resulted in a 34-dB PTA postoperative improvement. Two of the three patients with incus to oval window repairs experienced a 10-dB improvement in PTA. One of the three patients experienced a loss in speech discrimination and a 2-dB loss in PTA.
CONCLUSIONS: Despite the limited number of patients, this preliminary study demonstrates the effectiveness of Oto-Cem in reconstructing a foreshortened incus. There was a substantial hearing improvement in all but one patient in the incus to stapes or the incus to footplate categories.
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