Vocal fold augmentation with calcium hydroxylapatite: twelve-month report.

OBJECTIVES

To evaluate the long-term effectiveness of calcium hydroxylapatite (CaHA) vocal fold injection for patients with glottal insufficiency.

STUDY

DESIGN

Multicenter, open-label, prospective clinical study of CaHA vocal fold injection.

METHODS

Each patient served as his/her own control. Voice-related outcome measures were collected for pre-injection, 1, 3, 6, and 12 months.

RESULTS

Sixty-three patients were available for evaluation. Fifty-three percent of the injection procedures were done in the office. Fifty-seven percent of patients were diagnosed with unilateral paralysis and 43% with glottal incompetence with mobile vocal folds. Patient satisfaction 12 months after injection showed 67% reporting a significant improvement in voice and 81% reporting at least a moderate improvement in voice. Utilizing the Voice Handicap Index-10, visual analog scale (vocal effort), Consensus Assessment Perceptual Evaluation V (judgments of voice severity), and objective voice measures of glottal closure (maximum phonation time and S:Z ratio), paired t tests showed significant improvements after treatment. A 22% further treatment rate was found at the 12-month time point.

CONCLUSIONS

One-year results in this large cohort of patients with glottal incompetence treated with CaHA vocal fold injection demonstrate that excellent clinical results were achieved.