Surgical repair of bone defects of the ear canal wall with flexible hydroxylapatite sheets: a pilot study.

OBJECTIVE: Evaluation of suitability of flexible composite sheets (hydroxylapatite and polymer) for outer ear canal (OEC) wall reconstruction in tympanoplasty.

STUDY DESIGN: Prospective, open label pilot study.

SETTING: University and regional hospital.

PATIENTS: Forty-two randomly selected patients with chronic otitis media (n = 20) and cholesteatoma (n = 22) among 356 patients admitted between 1996 and 1997.

INTERVENTIONS: Eradication of disease through a partial or total canal wall down mastoidectomy; immediate reconstruction of canal wall with flexible composite sheet (hydroxylapatite and polymer) and connective tissue graft.

OUTCOME MEASURES: Anatomic integrity of the OEC and neotympanum, extrusion rate, complications.

RESULTS: At minimum follow-up of 24 months: recurrent cholesteatoma (n = 0), residual cholesteatoma (n = 3/22) (13.6%) in the mesotympanum (none behind the hydroxylapatite sheet or in the attic or antrum). The neotympanum was intact in 38 ears (90.4%), reperforated in 2, and severely retracted and lateralized in 1, respectively. Anatomic integrity of the OEC was obtained in 37 (88%) of 42 patients; stenosis or membranous synechiae were observed in 5 ears and treated in the office. Extrusion of the hydroxylapatite sheet occurred in 7 patients (16.6%) because of purulent otorrhea and granulation tissue formation. Surgical revision achieved complete epithelialization of the rebuilt canal wall in 33 ears (78.6%).

CONCLUSIONS: A dry, disease-free ear and normal anatomy may be expected 2 years postoperatively in more than three-fourths of the patients treated using the described surgical technique. Complete protection with a connective tissue graft is essential to avoid extrusion of the implant. The failure rate is significantly higher if otorrhea is present at the time of the operation.