A prospective randomised study of the early complication rates of hydroxyapatite versus Medpor orbital implant in the post-enucleation and evisceration socket
ISRCTN | ISRCTN55878769 |
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DOI | https://doi.org/10.1186/ISRCTN55878769 |
Secondary identifying numbers | N0547145274 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 16/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A Ang
Scientific
Scientific
Ophthalmology Department
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A prospective randomised study of the early complication rates of hydroxyapatite versus Medpor orbital implant in the post-enucleation and evisceration socket |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Surgery: Orbitant implants |
Intervention | Hydroxyapatite versus Medpor |
Intervention type | Procedure/Surgery |
Primary outcome measure | Rate of complication within the first 3 months post surgery. |
Secondary outcome measures | Number of additional unplanned surgical procedures in that period. |
Overall study start date | 01/10/2003 |
Completion date | 01/10/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 80 |
Key inclusion criteria | All patients having an eyeball removed and having orbital implants inserted at the same operation. |
Key exclusion criteria | Patients who are having implants inserted in a secondary procedure. |
Date of first enrolment | 01/10/2003 |
Date of final enrolment | 01/10/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
East Norfolk and Waveney Research Consortium - Norfolk and Norwich University, Hospital/Norwich PCT (UK), NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |