Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures (NCT07608380) | Clinical Trial Compass
By InvitationNot Applicable
Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures
Egypt8 participantsStarted 2025-11-01
Plain-language summary
The goal of this clinical trial is to evaluate the accuracy and stability of positioning guides and customized titanium plates in the treatment of Zygomaticomaxillary Complex (ZMC) fractures. The main questions it aims to answer are:
* Is the anatomical reduction achieved using a virtual planning-based positioning guide accurate when compared to preoperative plans?
* Does the customized titanium plate provide stable fixation during the follow-up period?
Researchers will compare the actual postoperative outcome to the preoperative virtual surgical plan to see if the customized workflow improves anatomical alignment.
Participants will:
* Undergo a preoperative Computed Tomography (CT) scan for virtual surgical planning.
* Receive surgical treatment using a patient-specific positioning guide and customized titanium plate.
* Complete follow-up assessments including postoperative CT scans and clinical evaluations for 6 months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed with Zygomatico-maxillary complex fractures requiring surgical intervention.
* Patients aged 18 years or older.
* Patients willing to provide informed consent and comply with follow-up protocols.
* Patients with adequate bone quality and quantity for stable fixation.
Exclusion Criteria:
* Patients with comminuted ZMC fractures that preclude the use of custom-made guides based on mirroring the contra lateral side.
* Patients with pre-existing facial deformities or asymmetries that would interfere with accurate assessment of fracture reduction.
* Patients with systemic diseases or conditions that contraindicate elective surgery or impair bone healing (e.g., uncontrolled diabetes, severe osteoporosis, active malignancy, and immunosuppression).
* Patients on medications affecting bone metabolism (e.g., long-term corticosteroids, bisphosphonates). Patients with active infections in the maxillofacial region.
* Pregnant or lactating women.
* Patients with psychiatric disorders or unrealistic expectations.
* Patients who are unable to undergo CT scans or follow post-operative instructions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.