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Efficacy of cartilage palisade tympanoplasty: randomized controlled trial
1Department of Otolaryngology, La Mancha Centro General Hospital, Alcázar de San Juan, Ciudad Real, Spain. jcabra@ya.com
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.
