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

NCT05672056 | Unknown

• 1 other identifier: MohamedGhorabPHD
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Linear deviation of anatomical landmarks between postoperative outcome and preoperative virtual plan

  Continuous numerical (mm)

  immediately on the post op CT scans

Study Arms (1)

Intervention

EXPERIMENTAL

The intervention will be modifying stock reconstruction plates to mimic patient specific plates in mandibular reconstruction with free fibula flaps

Procedure: Computer guided placement of a stock plate pre-bent on a 3D printed model

Interventions

Computer guided placement of a stock plate pre-bent on a 3D printed model PROCEDURE

We aim to design a novel guide that can secure the construct of the fibular segments and pre bent plate onto the native mandible and effectively and efficiently translate the VSP into the surgical field.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with segmental mandibular defects who are planned for free fibula flap reconstruction
• Patients presenting either for immediate reconstruction following resection of tumor or presenting for secondary reconstruction

You may not qualify if:

• Known allergies or sensitivities to materials such as titanium or acrylic or resin.
• Inability to return for follow up visits.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University - Faculty of Oral and Dental Medicine

Cairo, 12111, Egypt

RECRUITING

Related Publications (3)

• Ciocca L, Mazzoni S, Fantini M, Persiani F, Baldissara P, Marchetti C, Scotti R. A CAD/CAM-prototyped anatomical condylar prosthesis connected to a custom-made bone plate to support a fibula free flap. Med Biol Eng Comput. 2012 Jul;50(7):743-9. doi: 10.1007/s11517-012-0898-4. Epub 2012 Mar 24.

  PMID: 22447348 BACKGROUND

• Khatib B, Couey M, Patel A, Cheng A, Bell RB. "Custom" Plate in a Day-Accurate Predictive Hole Fabrication Using Point-of-Care 3-Dimensional Printing. J Oral Maxillofac Surg. 2022 Mar;80(3):559-568. doi: 10.1016/j.joms.2021.11.020. Epub 2021 Dec 4.

  PMID: 34958739 BACKGROUND

• Mascha F, Winter K, Pietzka S, Heufelder M, Schramm A, Wilde F. Accuracy of computer-assisted mandibular reconstructions using patient-specific implants in combination with CAD/CAM fabricated transfer keys. J Craniomaxillofac Surg. 2017 Nov;45(11):1884-1897. doi: 10.1016/j.jcms.2017.08.028. Epub 2017 Sep 5.

  PMID: 28965991 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator in Oral and Maxillofacial surgery department

Model Details: Pilot study.

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 5, 2023
• Study Start: May 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

EG (1)