An interventional study of Orbital floor reconstruction with Patient Specific Zirconia Implant and Orbital floor reconstruction with Patient Specific Titanium Implant in Blow-Out Fractures, Orbital Fractures and Orbital Floor Fracture, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures .
Patients of both groups will be subjected to:
Virtual planning:
The designed part will be subtracted then exported in Stereolithography (STL) format to be fabricated .
The surgery will be done under General anesthesia and undertaken within 14 days to prevent fibrosis. Can be delayed 24-72 hours to allow the edema to subside before undertaking surgery.
Intervention Group: -
Control Group: -
Follow up:
All patients will be examined clinically and radiographically, during postoperative 1st and 2nd week .
Only one postoperative CT scan will be done after 2 weeks.
29 studies on the registry are indexed under Orbital Fractures; 6 are open to participants now.
This study's planned enrollment of 20 is below the median of 28 across 20 interventional studies indexed under Orbital Fractures.
Browse Orbital Fractures studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Orbital floor reconstruction with Patient Specific Zirconia Implant will be done
Procedure: Orbital floor reconstruction with Patient Specific Zirconia Implant
Orbital floor reconstruction with Patient Specific Titanium Implant will be done.
Procedure: Orbital floor reconstruction with Patient Specific Titanium Implant
Orbital floor reconstruction with Patient Specific Zirconia Implant will be done
Orbital floor reconstruction with Patient Specific Titanium Implant will be done
Orbital Volume
will be measured with CT scan in mm3
Time frame: immediately post operative
Accuracy of the patient specific implant in the orbital floor reconstruction
will be measured with CT scan with superimposition of the preoperative CT scan and the mirrored image and the post operative CT scan . The difference will be measured by mm
Time frame: immediately post operative
Cost effectiveness
will compare between the prices of the patient specific implants the titanium and the zirconia and financial record will be kept with that in United states dollar . By the end of the study and comparison will be done to check which one was more cost effective
Time frame: through study completion, an average of 1 year
Patient satisfaction
will be assessed by a Questionnaire using Visual analogue scale , highest score will be more satisficed .The score is minimum 1 and maximum 10.
Time frame: through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Aug 2025, 16 months after the start.
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