An interventional study of orbital fracture reduction and fixation in Orbital Fractures, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
Open reduction and internal fixation of zygomaticomaxillary complex (ZMC) fractures has a challenging impact on the selection of the suitable surgical approach to the orbital and zygomatic skeleton. Precise repair of the ZMC fractures needs a quite understanding of the regional anatomy, precise diagnosis, an accessible exposure, and an accurate rigid fixation of fracture to restore the normal form. The aesthetic results are one of the most important requirements for these incisions in facial fracture reduction. Conventional approaches to the infraorbital rim/orbital floor include transcutaneous as subciliary, subtarsal and infraorbital incisions and transconjunctival incision. A thorough understanding of each incisional technique requires an appreciation of the relevant anatomy putting in considerations the risk of associated complications.
Aim of this study:To compare between transconjunctival approach and transcutaneous approaches in open reduction of zygomaticomaxillary fracture.
Materials and methods: A study will be made on 75 patients who will undergo fracture repair of the zygomaticomaxillary complex. Twenty five of them (group A) will be treated via a subtarsal approach while. Other Twenty five patients (group B) via a transconjunctival approach. The remaining Twenty five patients (Group C) will be treated via infraorbital appeoach. Postoperative patient evaluation will be performed with specific attention paid towards, accessibility, the exposure duration (time from incision till exposure of the field), esthetic appearance ,postoperative pain, postoperative edema , wound healing, scaring, infection and postoperative ocular complications such as ectropion, entropion, scleral show and corneal abrasion. Postoperatively clinical examination along with radiographic examination will be done to evaluate the position of the zygoma and determine the adequacy of fracture reduction.
Results: will be statistically analyzed using the IBM Statistical Package for Social Science (SPSS) software version 22.0
29 studies on the registry are indexed under Orbital Fractures; 6 are open to participants now.
This study's planned enrollment of 75 is above the median of 28 across 20 interventional studies indexed under Orbital Fractures.
Browse Orbital Fractures studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patient with orbital fractures (e.g., orbital floor or zygomaticomaxillary complex fractures) require open reduction with internal fixation.
Exclusion Criteria:
Existing lacerations in the inferior and lateral periorbital regions.
Other: orbital fracture reduction and fixation
Other: orbital fracture reduction and fixation
Other: orbital fracture reduction and fixation
orbital fracture reduction and fixation
operation time
starting from the skin incision till the reduction and fixation of the orbital rim
Time frame: intraopertive in minutes
accessibility
objective assessment by the main surgeon ( mild, moderate, excellent) accessibility
Time frame: intraopertive
wound healing 1
by Manchester scar scale
Time frame: 1, 2 and 8 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Nov 2026, 6 months after the start.
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