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.