Boomerang-Shaped Cartilage Graft in Endoscopic Tympanoplasty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this trial
This study evaluates the anatomical and functional outcomes of using a boomerang-shaped chondroperichondrial graft in endoscopic Type I tympanoplasty for repairing anterior or subtotal tympanic membrane perforations.
Anterior and subtotal eardrum perforations represent challenging surgical scenarios due to limited visualization, lack of anterior graft support, and higher risks of graft retraction, medialization, or residual perforation. The boomerang-shaped cartilage and perichondrium graft provides a sturdy cartilage framework along the anterior border to secure structural support, while maintaining a thin perichondrial layer over the functional vibratory area to facilitate acoustic transmission.
All enrolled participants undergo endoscopic Type I tympanoplasty using this autologous grafting technique. Follow-up assessments are conducted at 1, 3, and 6 months after surgery to determine successful graft uptake, evaluate hearing improvement (via pure-tone audiometry and air-bone gap closure), and monitor for complications such as blunting, retraction, lateralization, or infection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Anterior or subtotal tympanic membrane perforation
Dry ear for at least 3 months prior to surgery
Intact and mobile ossicular chain on clinical and intraoperative assessment
Disqualifiers
Active ear discharge at the time of surgery
Presence of cholesteatoma
Marginal or attic perforation associated with pathology requiring mastoid surgery
Ossicular discontinuity or erosion requiring ossiculoplasty
Trial design
Design model
Single group
Treatments tested in this trial
Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial Graft
Procedure/SurgeryEndoscopic Type I tympanoplasty performed using a rigid endoscope to repair anterior or subtotal tympanic membrane perforations. The autologous boomerang-shaped chondroperichondrial graft provides a stable anterior cartilage framework to prevent graft medialization, retraction, and residual perforation, while preserving a thin perichondrial layer over the functional vibratory surface to optimize acoustic transfer. Anatomical graft uptake and complication rates are monitored at 1, 3, and 6 months postoperatively, and functional hearing outcomes (pure-tone audiometry thresholds and air-bone gap closure) are measured at 6 months.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Boomerang-Shaped Chondroperichondrial GraftExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Graft Uptake Rate
Percentage of patients achieving complete anatomical closure and intact healing of the tympanic membrane perforation without residual defect, verified by postoperative otoscopic and endoscopic examination.
Time frame
6 months postoperativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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