A prospective randomised study of the early complication rates of hydroxyapatite versus Medpor orbital implant in the post-enucleation and evisceration socket
| ISRCTN | ISRCTN55878769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55878769 |
| Protocol serial number | N0547145274 |
| Sponsor | Department of Health |
| Funder | East Norfolk and Waveney Research Consortium - Norfolk and Norwich University, Hospital/Norwich PCT (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Rate of complication within the first 3 months post surgery. |
| Key secondary outcome measure(s) |
Number of additional unplanned surgical procedures in that period. |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
