Contact information
Type
Scientific
Primary contact
Mr MW Yung
ORCID ID
Contact details
The Ear Nose and Throat Department
Ipswich Hospital
Heath Road
Ipswich
Suffolk
IP4 5PD
United Kingdom
+44 (0)1473 703 527
matthew.yung@ipswichhospital.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0254119959
Study information
Scientific title
Acronym
Study hypothesis
Is there a difference in the efficacy and safety of the two most popular ossicular prostheses hydroxyapatite and titanium?
Ethics approval
Ethics approval was received from the local medical ethics committee in 2002 before trial recruitment began.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Ear, Nose and Throat: Middle ear reconstruction
Intervention
Comparing hydroxyapatite and titanium.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Hearing levels and air-bone gaps
Secondary outcome measures
Extrusion of prosthesis
Overall trial start date
10/01/2003
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Any patient requiring an alloplastic ossicular prosthesis.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Patients who do not have sufficient understanding of the information given to offer consent.
Recruitment start date
10/01/2003
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Ear Nose and Throat Department
Ipswich, Suffolk
IP4 5PD
United Kingdom
Sponsor information
Organisation
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ipswich Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20502377
Publication citations
-
Results
Yung M, Smith P, Titanium versus nontitanium ossicular prostheses-a randomized controlled study of the medium-term outcome., Otol. Neurotol., 2010, 31, 5, 752-758, doi: 10.1097/MAO.0b013e3181de4937.