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Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture

Evaluation of Modification of the Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04719312
Enrollment
15
Registered
2021-01-22
Start date
2019-03-03
Completion date
2020-10-07
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zygomatic Fractures

Brief summary

this study was made on fifteen patients who will undergo fracture repair of the zygomaticomaxillary complex. Postoperative patient evaluation performed with specific attention paid towards, accessibility the exposure duration(time from incision till exposure of the field), esthetic appearance, post-operative pain, post-operative edema, orbital movement, wound healing, scarring infection, and the post-operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion. Postoperative clinical examinations along with radiographic examination was done to evaluate the position of zygoma and determine the adequacy of fracture reduction.

Interventions

PROCEDUREY modification of transconjunctival approach

Section of the orbital septum is done at the Arcus Marginalis and subperiosteal dissection done to expose the infraorbital rim and orbital floor. Subsequently, canthotomy of the superficial limb of the lateral canthal ligament is performed and subperiosteal dissection is carried out to expose the fracture at the frontozygomatic region. The cutaneous Y will transform into a box when retracting its corners, increasing the working area and allowing access of the frontozygomatic (FZ) suture, lateral orbital wall, body of the zygoma, infraorbital rim, and floor of the orbit with a single approach. A small upper vestibular incision is placed to expose the fracture at the zygomatic buttress. Reduction and fixation of fractures in a regular fashion are accomplished.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Patients with ZMC fractures that requires open reduction with internal fixation. * Adult patient between 20 and 50 years with no gender predilections.

Exclusion criteria

* Existing lacerations in the inferior and lateral periorbital regions. * Comminuted fracture with bone loss. * Existence of infection at the fracture line. * Presence of Acute and chronic conjunctival diseases.

Design outcomes

Primary

MeasureTime frameDescription
The exposure durationat the surgeryThe time taken between performing the incision till exposure of the field
postoperative edemaafter 1 weekthe postoperative edema was categorized subjectively into mild (just noticeable), mild to moderate (more obvious edema without occlusion of palpebral fissure), moderate to severe (edema partially occluding palpebral fissure), and severe (edema totally occluding palpebral fissure).
change in postoperative pain24 hours, 48 hours, 1 weekassessed through a 10-point Visual Analogue Scale (VAS),(34) (0-1=none,2-4=mild,5-7=moderate,8-10=severe).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026