Health Condition 1: W499- Exposure to other inanimate mechanical forces
Conditions
Interventions
Intervention1: Group A Intervention arm (Fixation Sequence A -Alternate Sequence):
Infraorbital rim (Orbital floor if needed) then Frontozygomatic suture (ZM arch if needed) then Zygomaticomaxillary
Sponsors
AIIMS JODHPUR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age equal to or less than 16 years (less than 18 years with parental consent) 2. Unilateral ZMC indicated for ORIF 3. All unilateral ZMC fracture with any fractures which does not alter the orbital volume are included in this study (e.g.- Mandibular fractures and Lefort I, Frontal bone fractures and dentoalveolar fractures etc) 4. Informed consent for use of radiographic and clinical data 5.Surgery performed within 21 days of injury.
Exclusion criteria
Exclusion criteria: Bilateral ZMC fractures and if ZMC fractures is associated with any of the maxillofacial fractures disrupting any of the orbital wall will be excluded from the study (e.g. Lefort II, Lefort III, NOE, Pan facial Fractures etc.) Pre-existing orbital pathology/deformity Pathological or iatrogenic fractures. Previous orbital/facial surgery Chronic debilitating disease like high-risk pregnancy patients where GA cannot be administered will be excluded from this study. Open-globe or severe ocular injuries precluding accurate orbital assessment will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of alteration in reduction and fixation sequence on restoration of orbital volume in ZMC fractures using 3D computed tomography-based volumetric analysis post-surgicallyTimepoint: preop(Day 0) , 48 hours post op and after 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess clinical improvement in ocular parameters such as diplopia, exophthalmos, enophthalmos, dystopia (vertical and horizontal) and pre- and post-operatively. Timepoint: Day 0, 48 hrs, Day 7th, Day 15th , 1 month;2.To evaluate the aesthetic outcome in terms of malar prominences using clinical and radiographic analysisTimepoint: Day 0, 48 hrs post op, 3rd monnth;3. To compare surgical time, intra-operative ease and surgical satisfaction between different fixation sequences.Timepoint: Day 0;4. To assess patient satisfaction regarding his aesthetics, malar prominences, orbital changes using 5-point Likert scaleTimepoint: Day 0, 48hrs post op, Day 7th, Day 15th, 1 month;5. To assess if there is any change in volume of infraorbital foramen post fixation and its clinical implication on infraorbital paraesthesia in both the groupsTimepoint: Day 0, Day 15th, 1 month;6. To assess the incidence of bells phenomenon, oculotrigeminocardiac reflex, RAPD etc, if occurring in all the patientsTimepoint: Day 0;7. To assess the incidence and further compare the occurrence of post operative complications like infection, implant displacement, screw loosening, need for resurgery, etc in both the groups. Timepoint: Day 0, 48 hrs, Day 7th, Day 15th, 1 month | — |
Countries
India
Contacts
Public ContactShreyas Shikhare
AIIMS
Outcome results
None listed