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The accuracy of reconstruction of orbital wall fractures using prebent mesh versus patient specific implants: a randomized clinical trial
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The accuracy of reconstruction of orbital wall fractures using prebent mesh versus patient specific implants: a randomized clinical trial
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Journal Article
The accuracy of reconstruction of orbital wall fractures using prebent mesh versus patient specific implants: a randomized clinical trial
2025
Overview
Background
Repairing fractures of the orbital wall and floor remains a complex challenge due to the intricate anatomy of the orbit and the limited visibility during surgery. With the advancement of digital technologies, tools such as DICOM (Digital Imaging and Communications in Medicine) now allow the creation of virtual mirrored models of the unaffected orbit, which can greatly assist in surgical planning and reconstruction. This study aimed to evaluate the accuracy of orbital wall reconstruction using patient-specific implants (PSIs) versus prebent titanium mesh.
Materials and methods
A single-blind randomized controlled clinical trial was carried out on 28 patients with unilateral orbital fractures, who were randomly divided into two equal groups. Group I underwent orbital wall reconstruction using prebent titanium mesh, while Group II received titanium PSIs. Clinical and radiographic evaluations were carried out at 1 week, 1 month, and 3 months postoperatively to evaluate enophthalmos, ocular motility, diplopia, and the precision of orbital volume restoration.
Results
The mean postoperative orbital volume was 27.48 ± 1.324 cm³ in Group I and 25.62 ± 1.492 cm³ in Group II. The difference in orbital volume between the reconstructed and intact orbit was significantly smaller in the PSI group (0.6543 ± 0.2767 cm³) compared to the pre-bent mesh group (1.666 ± 0.3884 cm³;
p
< 0.05).
Conclusion
Patient-specific titanium implants significantly improved the accuracy of orbital volume restoration, particularly in cases involving large defects. Compared to pre-bent titanium mesh, PSIs reduced the need for revision surgery and offered superior volumetric outcomes. In contrast, prebent titanium mesh still provided satisfactory results for isolated single wall fractures and is likely to be cost-effective.
Trial registration
This trial was retrospectively registered at ClinicalTrials.gov on March 05, 2024, under the registration number NCT06294535.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
Subject
/ Accuracy
/ Adult
/ Assaults
/ CAD
/ Diplopia
/ Eye
/ Female
/ Humans
/ Injuries
/ Male
/ Medicine
/ Methods
/ Motility
/ Oral and Maxillofacial Surgery
/ Orbital Fractures - diagnostic imaging
/ Patients
/ Plastic Surgery Procedures - instrumentation
/ Plastic Surgery Procedures - methods
/ Skull
/ Software
/ Surgeons
/ Titanium
/ Trauma
