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Modified Anatomical Mesh in the Management of Orbito-Zygomaticomaxillary Complex Fractures: A Randomized Clinical
Mohab Ahmed Thabet Mahmoud1, Adham El Ashwah1, Yehia El-Mahallawy1
1Faculty of Dentistry, Oral and Maxillofacial Surgery Department, Alexandria University, Alexandria, Egypt.
Background:
Repair of unstable orbito-zygomaticomaxillary complex (OZMC) fractures with orbital floor defects (OFDs) may result in post-traumatic enophthalmos and asymmetry.
Purpose:
To measure and compare the efficacy of three-dimensional (3D)-modified anatomic mesh (3D-MAM) versus the conventional open reduction and internal fixation configuration in the operative treatment of OZMC fractures with OFD.
Study Design, Setting, And Sample:
Randomized controlled study conducted at Alexandria University, Egypt. The study enrolled subjects who presented with unilateral OZMC fracture with concurrent OFD, excluding those with isolated orbital or zygomatic fracture, or bilateral OFD.
Predictor Variable:
The type of fixation hardware, with subjects randomized to 3D-MAM or conventional hardware fixation (CHF) configuration.
Outcome Variable(S):
The primary outcome variable was the radiographic assessment of the globe position and comparing it to the healthy contralateral side. Secondary outcomes included clinical postoperative ocular complications, tarsal plate morphology, postoperative edema and ecchymosis, and infraorbital nerve sensory recovery.
Covariates:
Controlled variables were grouped into demographic and operative covariates.
Analyses:
χ2, Mann-Whitney, Friedman, and paired t-tests were used for inferential assessment. The intraclass correlation coefficient (ICC) was used for the assessment of the degree of agreement between preoperative and postoperative globe enophthalmos. Statistical significance was set at P < .05.
Results:
The cohort was composed of 24 subjects with a mean age of 27.67 (7.27) and a 2:1 male-to-female ratio. Preoperative binocular diplopia resolved completely in all 9 reported cases by the first follow-up session. Initial scleral show affected 50% of patients in both groups (6 cases each), which significantly improved over time (P3D-MAM = 0.02, PCHF = 0.002). Postoperative globe position reported a radiographic mean difference from the healthy side of 0.13 (0.39) for the 3D-MAM and -0.73 (0.49) for the CHF group. While both groups avoided clinical enophthalmos, the 3D-MAM group demonstrated an excellent degree of agreement between the preoperative and postoperative globe position (ICC 3D-MAM = 0.84, ICC CHF = 0.61).
Conclusions And Relevance:
Compared to conventional modalities, the novel 3D-MAM effectively manages OZMC fractures with OFD, demonstrating superior precision in restoring globe position without clinical ocular complications. 3D-MAM provides a more predictable anatomical OFD repair and stable fixation for OZMC fractures.
