Comparison of Hearing results after stapedotomy: fluoroplastic Causse Loop Piston versus Big Easy Piston

Comparison hearing results in patients with fluoroplastic Causse Loop Piston versus platinum/titanium (Big Easy) Piston in stapedotomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014011615496N3

Enrollment

170

Registered

2015-08-06

Start date

2009-01-01

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otosclerosis. Otosclerosis involving oval window, nonobliterative

Interventions

Intervention 1: stapedotomy with polycell prostesis in control group. Intervention 2: stapedotomy with Big Easy Piston prostesis in interventinal group.

Treatment - Surgery

stapedotomy with polycell prostesis in control group

stapedotomy with Big Easy Piston prostesis in interventinal group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criterion: 1) Patients who suffered from otosclerosis and undergone stapedotomy with Causse Loop Piston prosthesis (Medtronic Xomed, Jacksonville, FL) or Big Easy Piston prosthesis (Medtronic Xomed, Jacksonville, FL). Exclusion criteria: 1) All Patients who underwent stapedectomy; 2) Revision cases; 3) Patients who underwent stapedotomy for reasons other than otosclerosis, such as: congenital stapes fixation, malleus head fixation, trauma, chronic otitis media, and tympanosclerosis plaque; 4) Inadequate follow-up(less than 6 months) after surgery.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Hearing results. Timepoint: before operation -6 months after operation. Method of measurement: pure tone audiometry.	—

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026