Stabilising total ossicular replacement prosthesis for ossiculoplasty with an absent malleus in canal wall down tympanomastoidectomy - a randomised controlled study

Clin Otolaryngol. 2011 Dec;36(6):543-9. doi: 10.1111/j.1749-4486.2011.02406.x.

Abstract

Objectives: To compare two titanium total ossicular replacement prosthesis (TORP) stabilisation techniques in canal wall down mastoidectomy presenting with footplate only and absent malleus handle.

Design: Prospective, controlled, randomised study.

Setting: Tertiary Otology Department.

Participants: Patients operated on with canal wall down mastoidectomy between 1999 and 2009 were randomised into two groups. Two techniques enhancing the TORP stability were compared: Hüttenbrink's method (63 patients, Group 1) and author's (GB) procedure (62 patients, Group 2). Hüttenbrink's technique consists in placing a cartilage shave with a hole in the middle over the footplate. Through this hole, the end of the TORP is accommodated. The author's method involves using a cartilage split in the middle, to lodge the TORP's shaft at one end and to lay the opposite end over the fallopian canal.

Main outcome measures: Mean postoperative air-bone gap, hearing gain and air-bone gap closure within 20 dB. Auditory outcomes were evaluated at 1 year postoperatively.

Results: Postoperative air-bone gap closure within 20 dB (successful outcome) at 1 year was achieved in 59% of patients in Group 1 and 72% in Group 2 (P = 0.03). Mean postoperative air-bone gap was 24.4 ± 10.8 dB for Group 1 and 20.17 ± 9.8 dB for Group 2. The difference is 4.23 dB (95% confidence interval, 0.65-07.81), statistically significant: P = 0.02. Hearing gain was 20.3 ± 9.5 in Group 1 and 25.1 ± 10.2 in Group 2, significantly superior: P = 0.007.

Conclusion: Better hearing outcomes for author's method could be demonstrated, but our sample size cannot exclude small and possible trivial, group differences.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Audiometry, Pure-Tone
  • Cholesteatoma, Middle Ear / complications
  • Cholesteatoma, Middle Ear / physiopathology
  • Cholesteatoma, Middle Ear / surgery*
  • Female
  • Follow-Up Studies
  • Hearing
  • Humans
  • Male
  • Malleus / abnormalities*
  • Mastoid / surgery*
  • Middle Aged
  • Ossicular Prosthesis*
  • Otitis Media / complications
  • Otitis Media / physiopathology
  • Otitis Media / surgery*
  • Prospective Studies
  • Prosthesis Design
  • Titanium
  • Treatment Outcome
  • Tympanoplasty / methods*

Substances

  • Titanium