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Recruiting NCT05672056

Novel Application of a Low-cost Alternative to Patient Specific Implants (PSI) in Mandibular Free Fibula Flap Reconstruction by Reverse Engineering of Stock Plates: A Pilot Validation Study

Conditions: Fibula / Surgery, Surgical Flaps, Computer-Aided Design, Mandibular Reconstruction* / Methods, Surgery, Computer-Assisted

Sex: All
Healthy volunteers: 1
Phase: NA
Enrollment: 8
Sponsor: Cairo University

Location: Egypt

Summary

Stock reconstruction plates have been used for decades and represent a tried-and-true alternative to custom plating. Stock plates are readily available, are cost effective, and can be accurately bent before surgery, particularly when using stereolithographic models. Unfortunately, the use of stock plates typically precludes the utilization of predictive holes; this can make inset more difficult as the plates do not precisely match the native mandibular contour. Previous descriptions of fabricating predictive holes with stock plates have been inaccurate and inefficient.We aim with conducting this research to improve on the ability of pre-bent stock plates of reproducing the VSP in the operating theater allowing accurate native mandible fixation, accurate fibular segments harvest and accurate inset of the reconstruction in lieu of using the expensive alternative of PSI, thus expanding the use of VSP in mandibular reconstruction in resource limited institutions.

Eligibility Criteria

Inclusion Criteria:Patient with segmental mandibular defects who are planned for free fibula flap reconstructionPatients presenting either for immediate reconstruction following resection of tumor or presenting for secondary reconstructionExclusion Criteria:Known allergies or sensitivities to materials such as titanium or acrylic or resin.Inability to return for follow up visits.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05672056). StuddyBuddy aggregates publicly available trial information.