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Not yet recruitingNCT07866222Updated Oct 8, 2026

Outcomes of Cartilage Tympanoplasty in Children

An interventional study of Cartilage Tympanoplasty in Tympanic Membrane Perforation, Conductive Hearing Loss and Chronic Otitis Media, sponsored by Assiut University. Not yet recruiting. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
8 Years to 18 Years
Sex
All
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Study summary

This study evaluates the anatomical and hearing outcomes of cartilage tympanoplasty in pediatric patients with chronic tympanic membrane perforations.

A perforation (hole) in the eardrum in children can lead to recurrent ear discharge, chronic middle-ear infections, and conductive hearing loss. Cartilage tympanoplasty is a surgical technique that uses autologous cartilage (the patient's own cartilage tissue) to reconstruct and seal the eardrum. Cartilage is known for its rigidity and resistance to retraction, which may offer advantages in children who frequently experience middle-ear pressure and ventilation issues.

Children aged 8 to 18 years presenting with large, subtotal, or persistent dry central perforations will undergo cartilage tympanoplasty at Assiut University Hospitals. All participants will undergo standardized pre-surgical and post-surgical evaluations, including otological microscopic examinations and pure-tone audiometry tests.

The main objectives are to evaluate the graft success rate (complete anatomical closure and stability of the eardrum) and to measure functional hearing restoration, specifically changes in air-conduction thresholds and the air-bone gap (ABG).

02

Conditions studied

  • Tympanic Membrane Perforation
  • Conductive Hearing Loss
  • Chronic Otitis Media

Keywords

  • Cartilage tympanoplasty
  • Pediatric tympanoplasty
  • Myringoplasty
  • Tympanic membrane repair
  • Air-bone gap
  • Graft take rate
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In context

Tympanic Membrane Perforation

45 studies on the registry are indexed under Tympanic Membrane Perforation; 10 are open to participants now.

This study's planned enrollment of 35 is below the median of 57 across 31 interventional studies indexed under Tympanic Membrane Perforation.

Browse Tympanic Membrane Perforation studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children aged 8-18 years
  • Large, subtotal central tympanic membrane perforation or persistent same-size central perforation for 6 months before surgery
  • Dry perforation for 6 months duration
  • Conductive hearing loss attributable to tympanic membrane perforation
  • Patients able to undergo preoperative and postoperative audiological assessment
  • Written informed consent obtained from the parent/legal guardian and assent from the child when appropriate

Exclusion criteria

Exclusion Criteria:

  • Cholesteatoma
  • Active ear infection at the time of surgery
  • Sensorineural hearing loss unrelated to the tympanic membrane perforation
  • Conductive gap > 40 dB (suggestive of ossicular chain pathology)
  • Congenital middle-ear abnormalities affecting the surgical outcome
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Cartilage Tympanoplasty

    Pediatric patients aged 8 to 18 years undergoing surgical repair of large, subtotal, or persistent central tympanic membrane perforations using autologous cartilage tympanoplasty to assess anatomical graft uptake and hearing restoration.

    Procedure: Cartilage Tympanoplasty

Interventions

  • ProcedureCartilage Tympanoplasty

    Surgical reconstruction of the tympanic membrane using an autologous cartilage graft in pediatric patients presenting with large, subtotal, or persistent central perforations. The procedure is performed under general anesthesia to achieve complete anatomical closure of the perforation and restore middle-ear sound conduction.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Complete Tympanic Membrane Closure

    Assessed by otoscopic and microscopic examination. Complete closure is defined as an intact, fully epithelialized, and stable graft without residual perforation, graft retraction, or lateralization.

    Time frame: 6 months postoperatively

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07866222
Lead sponsor
Assiut University
Responsible party
Hasnaa Hussein Mahmoud (Resident, Assiut University) — Principal investigator
First posted
Oct 8, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 8, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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