Zygomatic Fractures
Conditions
Keywords
Zygomatic fracture, computer guided surgery, patient specific implant, predictive holes surgical guide, Zygomatico-Maxillary complex fracture
Brief summary
this study aims To evaluate The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fracture reduction and fixation Using customized Patient-Specific implant and patient-specific predictive holes surgical guide Versus Conventional Technique of reduction and fixation.
Detailed description
The ZMC has multiple points of articulation with the craniofacial skeleton making accurate assessment of reduction at all articulations intraoperative in multiple planes very challenging and the interference of soft tissue edema and a narrowed visual field increases the possibility of intraoperative overcorrection or underestimation of pre-injured position of all fracture lines at the same time resulting in a suboptimal reduction. As a trial to maximize the benefits of digital planning carrying the plan into a real operating room using a patient-specific surgical guide to predrill screw holes and guide patient-specific implants during fixation according to the planning depend on CT scan.
Interventions
PROCEDUREReduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow
All surgeries will be carried out under general anesthesia the fracture lines will be exposed then For the study group: following the exposure of all fracture lines , anatomically seated bone-supported predictive holes surgical guides will be inserted on the bone segments with intimate contact. Each segment hole will be drilled according to the predesigned predictive holes guide. The fractured segments will then be reduced and fixed using titanium miniplates customized for the patient and screws at least two screws for each fracture segment. then closure in layers will be performed using absorbable vicryl for deep layers and intraoral sutures and non-absorbable polyproline for skin closure.
PROCEDUREReduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol
For the control group: all cases will be treated under general anesthesia and the fracture lines will be exposed then the conventional protocol of treatment depend mainly on visualization of the fracture line and tactile sensation of the operator intra-operative during reduction procedure and the fixation of fractured segments will be done using titanium miniplates and screws then closure in layers will be performed.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Zygomatic Fracture Types III, IV, V, VII, and VIII according to Rowe and Killey's classification. * Age range (18-60 years). * Patients are willing for the surgical procedure and follow-up, with informed consent
Exclusion criteria
* Zygomatic Fracture Type I, II according to Rowe and Killey's classification. * Patients with contraindications for general anesthesia. * Patient on radiotherapy. * Patients suffer from bone disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zygomatic reposition | immediate postoperative | the accuracy of zygomatic bone reduction and fixation using postoperative CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative time | during the operation | duration of operation using stopwatch |
| paresthesia | pre operative, immediate postoperative and 6 months post operative | sensation in the area supplied by the infraorbital nerve using a 2 points discrimination test |
| patient satisfaction | 6 months postoperative | patient aesthetic satisfaction will be measured using a visual analogue scale from 0 to 10 in a questionnaire form, zero mean not satisfied at all and 10 is the maximum satisfaction. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORDina Ayman Fayek, M.Sc
Assistant lecturer oral and maxillofacial surgery department Future university in Egypt
Outcome results
None listed