Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Editorial Notes