Boomerang-Shaped Cartilage Graft in Endoscopic Tympanoplasty

NCT07823894 | Not Yet Recruiting

• 1 other identifier: Boomerang Graft Tympanoplasty
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tympanic Membrane Perforation; Chronic Otitis Media

Keywords

Endoscopic tympanoplasty; Type 1 tympanoplasty; Boomerang-shaped graft; Chondroperichondrial graft; Cartilage tympanoplasty; Anterior perforation; Subtotal perforation; Graft uptake

Outcome Measures

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.

  6 months postoperatively

Study Arms (1)

Boomerang-Shaped Chondroperichondrial Graft

EXPERIMENTAL

Patients undergo endoscopic Type I tympanoplasty using an autologous boomerang-shaped chondroperichondrial graft for the repair of anterior or subtotal tympanic membrane perforations. Graft uptake, audiometric outcomes (pure-tone audiometry thresholds and air-bone gap closure), and postoperative complications are assessed over a 6-month follow-up period.

Procedure: Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial Graft

Interventions

Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial Graft PROCEDURE

Endoscopic 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.

Boomerang-Shaped Chondroperichondrial Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Aerated middle ear with healthy or near-normal middle ear mucosa
• No evidence of cholesteatoma
• Ability to attend all scheduled postoperative follow-up visits
• Provision of written informed consent

You may not qualify if:

• 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
• Significant adhesive otitis media
• Previous failed tympanoplasty in the same ear
• Severe Eustachian tube dysfunction associated with adhesive disease
• Craniofacial anomalies affecting the ear
• Uncontrolled systemic disease contraindicating surgery
• Narrow external auditory canal precluding endoscopic access
• Inability to complete the planned follow-up period

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09