Efficacy of cartilage palisade tympanoplasty: randomized controlled trial.

Objectives: To calculate the efficacy (evaluating both morphologic and functional results) of cartilage palisade tympanoplasty (CPT) in comparison with tympanoplasty involving a temporalis muscle fascia (FT) graft.

Study Design: Randomized controlled trial.

Setting: General Hospital.

Patients: One hundred twenty-three patients with chronic otitis media who were recruited for the study between the years 1997 and 2002.

Intervention(s): Sixty-four patients were randomly allocated to the group receiving CPT and the remaining 59 to the group undergoing tympanoplasty with FT.

Main Outcome Measure: The primary endpoint was defined as "morphological success," a composite variable that includes the absence of perforation, atelectasis, atrophy, lateralization, otorrhea, and blunting. The secondary endpoints were defined as functional hearing results.

Results: Both treatment groups were homogeneous with regard to the main baseline characteristics studied. Morphologic success at 24 months in the CPT group was 51 of 62 (82.26%), whereas in the FT group, it was 38 of 58 (64.41%; p = 0.03; relative risk = 1.28; 95% confidence interval (CI) = 1.02-1.60). The relative risk for morphologic success, adjusted for a multivariate model, was 1.36 (95% CI = 1.11-1.38), whereas the adjusted NNT was 5 (95% CI = 4-15). No statistically significant differences were found between the functional results of both treatment groups.

Conclusion: Cartilage palisade tympanoplasty is a more effective technique for reconstructing the tympanic membrane than FT for the population studied.