A randomised study to compare hydroxyapatite and titanium prostheses in middle ear reconstruction

ISRCTN ISRCTN56190969
DOI https://doi.org/10.1186/ISRCTN56190969
Secondary identifying numbers N0254119959
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
27/10/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr MW Yung
Scientific

The Ear Nose and Throat Department
Ipswich Hospital
Heath Road
Ipswich, Suffolk
IP4 5PD
United Kingdom

Phone +44 (0)1473 703 527
Email matthew.yung@ipswichhospital.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title
Study objectivesIs there a difference in the efficacy and safety of the two most popular ossicular prostheses hydroxyapatite and titanium?
Ethics approval(s)Ethics approval was received from the local medical ethics committee in 2002 before trial recruitment began.
Health condition(s) or problem(s) studiedEar, Nose and Throat: Middle ear reconstruction
InterventionComparing hydroxyapatite and titanium.
Intervention typeOther
Primary outcome measureHearing levels and air-bone gaps
Secondary outcome measuresExtrusion of prosthesis
Overall study start date10/01/2003
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants100
Key inclusion criteriaAny patient requiring an alloplastic ossicular prosthesis.
Key exclusion criteriaPatients who do not have sufficient understanding of the information given to offer consent.
Date of first enrolment10/01/2003
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Ear Nose and Throat Department
Ipswich, Suffolk
IP4 5PD
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Ipswich Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2010 Yes No