Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Shaheed Beheshti Medical University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Shaheed Beheshti Medical University
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00371280
First received: September 1, 2006
Last updated: May 10, 2010
Last verified: June 2008
| Tracking Information | |||||
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| First Received Date ICMJE | September 1, 2006 | ||||
| Last Updated Date | May 10, 2010 | ||||
| Start Date ICMJE | November 2005 | ||||
| Estimated Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00371280 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Pegging the hydroxyapatite for increasing prosthetic motility sometimes leads to some complications for the patient. These complications ranging from discharge, granuloma formation, exposure, implant infection to socket discomfort and etc. We are going to compare prosthetic motility, objectively and subjectively (patients satisfaction) before and after pegging the hydroxy- apatite, and evaluate the complications after pegging. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: orbital implant
Implantation of pegged versus unpegged hydroxyapatite orbital implants |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | November 2006 | ||||
| Estimated Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00371280 | ||||
| Other Study ID Numbers ICMJE | 8422 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Shaheed Beheshti Medical University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Shaheed Beheshti Medical University | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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