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Background <p>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.</p> Materials and methods <p>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.</p> Results <p>The mean postoperative orbital volume was 27.48 ± 1.324&#xa0;cm³ in Group I and 25.62 ± 1.492&#xa0;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&#xa0;cm³) compared to the pre-bent mesh group (1.666 ± 0.3884&#xa0;cm³; <i>p</i> &lt; 0.05).</p> Conclusion <p>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.</p> Trial registration <p>This trial was retrospectively registered at ClinicalTrials.gov on March 05, 2024, under the registration number NCT06294535.</p>

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The accuracy of reconstruction of orbital wall fractures using prebent mesh versus patient specific implants: a randomized clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月1日

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  • Mona S. Sheta,
  • Wesam H. Elsaadany

摘要

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.