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A randomised study to compare hydroxyapatite and titanium prostheses in middle ear reconstruction
ISRCTN ISRCTN56190969
DOI 10.1186/ISRCTN56190969
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised study to compare hydroxyapatite and titanium prostheses in middle ear reconstruction
Scientific title
Acronym N/A
Serial number at source N0254119959
Study hypothesis Is there a difference in the efficacy and safety of the two most popular ossicular prostheses hydroxyapatite and titanium?
Lay summary
Ethics approval Ethics approval was received from the local medical ethics committee in 2002 before trial recruitment began.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Ear, Nose and Throat: Middle ear reconstruction
Participants - inclusion criteria Any patient requiring an alloplastic ossicular prosthesis.
Participants - exclusion criteria Patients who do not have sufficient understanding of the information given to offer consent.
Anticipated start date 10/01/2003
Anticipated end date 31/12/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet.
Target number of participants 100
Interventions Comparing hydroxyapatite and titanium.
Primary outcome measure(s) Hearing levels and air-bone gaps
Secondary outcome measure(s) Extrusion of prosthesis
Sources of funding Ipswich Hospital NHS Trust (UK)
Trial website
Publications 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20502377
Contact name Mr  MW  Yung
  Address The Ear Nose and Throat Department
Ipswich Hospital
Heath Road
  City/town Ipswich, Suffolk
  Zip/Postcode IP4 5PD
  Country United Kingdom
  Tel +44 (0)1473 703 527
  Fax +44 (0)1473 703 400
  Email matthew.yung@ipswichhospital.nhs.uk
Sponsor Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)207 307 2622
  Fax +44 (0)207 307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.doh.gov.uk
Date applied 12/09/2003
Last edited 27/10/2010
Date ISRCTN assigned 12/09/2003
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