Boomerang-Shaped Cartilage Graft in Endoscopic Tympanoplasty

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.

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Key information

Conditions

Tympanic Membrane Perforation Chronic Otitis Media Ear Diseases Otorhinolaryngologic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

Graft Uptake Rate

Time frame: 6 months postoperatively

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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Boomerang-Shaped Cartilage/Perichondrial Graft in Endoscopic Tympanoplasty for Anterior or Subtotal Tympanic Membrane Perforations

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 17, 2026
Registry last updated: Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed