Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0547145274
Study information
Scientific title
A prospective randomised study of the early complication rates of hydroxyapatite versus Medpor orbital implant in the post-enucleation and evisceration socket
Acronym
Study hypothesis
To determine in a prospective and randomised manner if hydroxyapatite or Medpor is associated with lower rate of complication in the early post-operative period (ie within 3 months of surgery).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Orbitant implants
Intervention
Hydroxyapatite versus Medpor
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Rate of complication within the first 3 months post surgery.
Secondary outcome measures
Number of additional unplanned surgical procedures in that period.
Overall trial start date
01/10/2003
Overall trial end date
01/10/2005
Reason abandoned
Eligibility
Participant inclusion criteria
All patients having an eyeball removed and having orbital implants inserted at the same operation.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
Patients who are having implants inserted in a secondary procedure.
Recruitment start date
01/10/2003
Recruitment end date
01/10/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
East Norfolk and Waveney Research Consortium - Norfolk and Norwich University, Hospital/Norwich PCT (UK), NHS R&D Support Funding
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