Otosclerosis is a most common cause of conductive hearing loss in adults. The aim of this study is comparing hearing improvement in patients with otosclerosis who underwent primary stapedotomy with Causse Loop Piston or Big Easy Piston prosthesis. This is a double blind randomized clinical study in a single center (Dastghaib Hospital Shiraz -Iran). Both of them audiologist who measured hearing outcome and statistician who analyzed data have been blinded. Patients divided in two groups: 89 Patients in Causse Loop Piston group and 70 Patients in Big Easy Piston. Inclusion criterion: Patients who suffered from otosclerosis and undergone stapedotomy with each of prosthesis as intervension. Exclusion criteria: Patients, who underwent stapedectomy and/or revision stapedotomy, Patients who underwent stapedotomy for reasons other than otosclerosis, patients with inadequate postoperative follow-up. Primary outcome was hearing results that were assessed 6 months after the operation and two groups were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011615496N3
Registration date:2015-08-06, 1394/05/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-06, 1394/05/15
Registrant information
Name
Sareh Roosta
Name of organization / entity
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5323
Email address
namazi_balini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2014-12-30, 1393/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison hearing results in patients with fluoroplastic Causse Loop Piston versus platinum/titanium (Big Easy) Piston in stapedotomy
Public title
Comparison of Hearing results after stapedotomy: fluoroplastic Causse Loop Piston versus Big Easy Piston
Purpose
Treatment
Inclusion/Exclusion 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.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street