In order to reconstruct sound conducting mechanisms in middle ear and stapedectomy, different prostheses have been used. Tephlon piston is one of the most common prosthesis used. Recently Titanium prosthesis are widely accepted in middle ear surgery due to their favorable characteristics such as endurance, low impedance, and being user friendly.
This study is designed to compare hearing outcome and complications of tephlon piston prosthesis and titanium in stapes surgery.
In this study 80 patients with otosclerosis diagnosed in Amir-Alam hospital will be randomly allocated into one of two arms 1) stapedectomy with tephlon piston, 2) stapedectomy with titanium soft-clip. For all of the patients thorough history and physical examination in addition to audiologic studies before and 2 months after surgery will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012061610041N1
Registration date:2012-09-25, 1391/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-25, 1391/07/04
Registrant information
Name
Ali Kouhi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 3037
Email address
a-kouhi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-08-01, 1391/05/11
Expected recruitment end date
2013-08-01, 1392/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Teflon-piston and titanium soft-clip KURZ prosthesis in hearing improvement and complications of stapedotomy in otosclerosis patients
Public title
Comparison of stapes surgery outcomes and complications with Teflon-piston and titanium soft-clip KURZ prosthesis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are diagnosed as otosclerosis and accepted surgical treatment.
Exclusion criteria:
History of previous ear surgery
Finding other than otosclerosis during surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Ghods Ave, Tehran University of Medical Sciecnes
City
Tehran
Postal code
Approval date
2012-09-08, 1391/06/18
Ethics committee reference number
91-02-48-18346-64002
Health conditions studied
1
Description of health condition studied
Otosclerosis
ICD-10 code
H80.1
ICD-10 code description
Otosclerosis involving oval window, obliterative
Primary outcomes
1
Description
Hearing threshold
Timepoint
before and 2 month after surgery
Method of measurement
Audiometry
Secondary outcomes
1
Description
Bone conduction threshold
Timepoint
before and 2 month after surgery
Method of measurement
Audiometry
Intervention groups
1
Description
Intervention: Stapedectomy and titanium soft-clip prosthesis placement
Category
Treatment - Surgery
2
Description
Control: Stapedectomy and tephlon piston prosthesis placement
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Alam hospital
Full name of responsible person
Ali Kouhi
Street address
North Saadi Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs Norouz zadeh
Street address
Keshavarz blvd, Ghods ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Kouhi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amir-Alam Hospital, North Saadi Ave
City
Tehran
Postal code
11457-65111
Phone
+98 21 6670 3037
Fax
+98 21 6676 0245
Email
a-kouhi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Kouhi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amir-Alam Hospital, North Saadi
City
Tehran
Postal code
11457-65111
Phone
+98 21 6670 3037
Fax
Email
a-kouhi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Kouhi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amir-Alam Hospital, North Saadi ave.
City
Tehran
Postal code
11457-65111
Phone
+98 21 6670 3037
Fax
+98 21 6676 0245
Email
a-kouhi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)