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.