Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures
Accuracy of Positioning Guide and Customized Titanium Plate for Reduction and Fixation of Zygomaticomaxillary Complex Fracture: A Case Series
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
The clinical workflow for managing unilateral Zygomaticomaxillary Complex (ZMC) fractures begins with a standardized diagnostic phase. Patients undergo a thorough medical and dental history followed by a comprehensive clinical examination. A high-resolution preoperative Computed Tomography (CT) scan (T0) is acquired within one week prior to the intervention to visualize fracture patterns and the extent of displacement. The Digital Imaging and Communications in Medicine (DICOM) data is imported into specialized medical imaging software, such as Materialise Mimics or 3-matic, for three-dimensional (3D) reconstruction and Virtual Surgical Planning (VSP).
During the digital planning phase, the fractured zygomaticomaxillary complex is virtually reduced by mirroring the unaffected contralateral side to achieve optimal anatomical symmetry. Based on this virtual model, a patient-specific positioning guide is designed to fit the bone surface and indicate exact locations for plate and screw placement. Simultaneously, a customized titanium plate is designed to conform perfectly to the reduced bone contours, incorporating optimal screw hole positions to maximize stability and avoid vital structures. These plates are fabricated using additive manufacturing techniques, specifically selective laser melting, to ensure high precision and biocompatibility.
The surgical procedure is performed under general anesthesia. Appropriate surgical approaches, including lateral eyebrow and intraoral vestibular incisions, are used to expose the fracture site. The positioning guide is utilized to facilitate the accurate relocation of ZMC fragments according to the preoperative virtual plan. Once the fracture is accurately reduced, the custom-made titanium plate is adapted to the bone surface and secured with screws to achieve rigid internal fixation, minimizing the need for intraoperative plate bending.
Postoperative care includes an immediate follow-up Computed Tomography (CT) scan (T1) within 1 to 3 days to assess the accuracy of fracture reduction and plate placement by superimposing the postoperative actual model onto the preoperative virtual plan. Clinical follow-up occurs at regular intervals (1 week, 1 month, 3 months, 6 months, and 1 year) to assess wound healing, facial symmetry, ocular function, and mouth opening. A long-term follow-up CT scan (T2) is obtained at 6 months to evaluate bone healing and the long-term stability of the fixation.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Cairo, Egypt
- department of oral and maxillofacial surgery, faculty of dentistry, Cairo university
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Virtual Planning and Customized Plates
Patients with ZMC fractures undergoing surgical treatment using 3D virtual planning and patient-specific titanium plates.
|
A 3D-printed positioning guide designed through virtual surgical planning to assist in the accurate reduction of ZMC fractures.
A custom-fabricated titanium plate designed to fit the patient's specific anatomy for rigid fixation of ZMC fractures.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Accuracy of Fracture Reduction
Časové okno: one week postoperative
|
Evaluation of the accuracy of fracture reduction achieved using the positioning guide and customized titanium plate.
This will be assessed by superimposing the post-operative computed tomography (CT) scans onto the pre-operative virtual surgical plan.
The difference will be reported as linear deviation, measured in millimeters (mm).
|
one week postoperative
|
|
Assessment of Facial Symmetry (Malar Projection)
Časové okno: 6 months postoperatively
|
Evaluation of aesthetic outcome and facial symmetry by assessing the malar projection.
This will be measured clinically or via imaging (e.g., comparing the fractured side to the intact side).
The outcome will be reported as the linear discrepancy or difference between the two sides, measured in millimeters (mm).
|
6 months postoperatively
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Assessment of Ocular Motility and Diplopia
Časové okno: 6 months postoperatively
|
Clinical assessment of functional recovery regarding ocular motility.
Patients will be clinically examined for the presence or absence of diplopia (double vision) in different fields of gaze.
The outcome will be reported as a categorical variable (e.g., Presence / Absence of diplopia).
|
6 months postoperatively
|
|
Total Operative Time
Časové okno: Day of surgery (Intraoperative)
|
The total duration of the surgical procedure measured in minutes, from the initial incision to the final closure.
|
Day of surgery (Intraoperative)
|
|
Patient Satisfaction
Časové okno: 6 months postoperatively
|
Evaluation of the patient's overall satisfaction with the functional and aesthetic outcomes of the procedure.
This will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates "completely dissatisfied" and 10 indicates "completely satisfied".
The reported value will be the numerical score on this scale.
|
6 months postoperatively
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Prof. Ramy Ragab Elbialy, prof. of maxillofacial surgery, Department of Oral and maxillofacial surgery,Faculty of dentistry, Cairo university
- Ředitel studie: Dr. Mohamed Ali Zain Elabden, lecturer of maxillofacial surg, department of oral and maxillofacial surgery, faculty of dentistry, Cairo university
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- OMFS3319
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .