Boomerang-Shaped Cartilage Graft in Endoscopic Tympanoplasty
Boomerang-Shaped Cartilage/Perichondrial Graft in Endoscopic Tympanoplasty for Anterior or Subtotal Tympanic Membrane Perforations
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Boomerang-Shaped Chondroperichondrial Graft
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Boomerang Graft Tympanoplasty
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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