The wheel-shaped composite cartilage graft (WsCCG) and temporalis fascia for type 1 tympanoplasty: a prospective, randomized study

To compare the anatomical and functional outcomes of two different grafts which are used for the reconstruction of subtotal or total tympanic membrane perforations: the wheel-shaped composite cartilage graft (WsCCG) and temporalis fascia (TF).

Ninety patients (94 ears) who underwent type 1 tympanoplasty for non-complicated chronic otitis media between March 2014 and June 2016 in a tertiary referral center were included in a randomized, controlled, prospective clinical trial. Tympanic membranes were reconstructed with the WsCCG or TF.

Outcomes of 91 surgeries performed on 87 adults (> 18 years of age) were evaluated in the study. Forty-three patients (44 ears) were included in the WsCCG group; 44 patients (47 ears) were included in the TF group. The mean post-operative follow-up was 14.9 months for the WsCCG group and 15.1 months for the TF group. There was no statistically significant difference in post-operative pure tone average (PTA) (p = 0.19), air-bone gap (ABG) (p = 0.64), PTA gain (p = 0.82) and ABG closure (p = 0.89) values between two groups. Graft success rates at 6 months after surgery were 82.9% (39/47) and 97.7% (43/44) for TF and WsCCG, respectively. At the first year, success rates were 85.1% (40/47) for TF and 97.7% (43/44) for WsCCG. A statistically significant difference was observed in graft success rates between two groups (p = 0.039).

Both TF and WsCCG lead to satisfactory functional results, but the WsCCG clearly leads to superior anatomical outcomes with a graft success rate of 97.7%. The WsCCG is a suitable graft for subtotal or total tympanic membrane perforations and has the advantages of being a one-piece, flexible, composite, and physically resistant graft.