Fibula / SurgeryNCT05672056
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
A study testing Computer guided placement of a stock plate pre-bent on a 3D printed model in people with Fibula / Surgery and Surgical Flaps, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fibula / Surgery, Surgical Flaps, Computer-Aided Design
- What is being tested?
- Computer guided placement of a stock plate pre-bent on a 3D printed model
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- May 2023to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known allergies or sensitivities to materials such as titanium or acrylic or resin.
- Inability to return for follow up visits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University - Faculty of Oral and Dental Medicine
Cairo, 12111
Mohamed Ghorab, MSc, 01002841441, ddsmghorab@gmail.com
About this study
Official title: Demonstrator in Oral and Maxillofacial Surgery Department
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.
Read the detailed description
Aim of the study:
The aim of the study is to evaluate the accuracy of mandibular reconstruction with free fibula flaps utilizing a novel design of resection and cutting guides based on reverse engineering stock plates into the VSP workflow.
Hypothesis:
The null hypothesis is that there is no significant difference between the postoperatively reconstructed mandible with free fibula flap and the virtually reconstructed mandible preoperatively
PICO:
Population (P): Patients with mandibular segmental defects who will receive free fibula flaps Intervention (I): Three-dimensionally printed guides based on VSP and reverse engineering for resection, predrilling of fixation holes, and shaping of the fibula segments Outcome (O): Accuracy of postoperative mandibular and fibular positions compared with the preoperative virtual surgical plan. In addition to patient reported satisfaction of functional and esthetic outcome. Finally, operative time will be recorded
Trial design:
validity study (pilot study)
Methods A) Participants, interventions \& outcomes
Study settings:
The patients will be recruited from the clinics of, the oral and maxillofacial surgery, Cairo University and the Head and neck unit in the National Cancer Institute.
Eligibility criteria:
Inclusion criteria
- 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
Exclusion criteria:
- Known allergies or sensitivities to materials such as titanium or acrylic or resin.
- Inability to return for follow up visits.
Post-operative accuracy evaluation:
- Post operative CT scans will be obtained within the first post operative month.
- The post operative DICOM will be segmented in software and the previously designed VSP model will be imported into the project and aligned by best fit algorithm to the unaffected portions of the skull.
- A color heat overlay map will be presented to evaluate the accuracy of reconstruction.
Several anatomical landmarks will be selected to calculate linear deviation measurements.
-Data collection methods Plans for assessment and collection of outcomes will be within the first post operative month and will be done by two assessors independently and inter-examiner calibration will be calculated through Kappa scoring as well as any differences will be solved by consensus. Data management Data will be recorded on diagnostic chart for each patient separately and will be stored with follow up photographs and clinical examination as well as patient's questionnaire. All data will be stored on laptop of the investigator, secured with a password with a backup on google drive and hard copy. The supervisors will have access on the data when needed. Statistical methods Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 24 (SPSS Inc., Chicago, IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Chi square test will be used for categorical data. Data will be explored for normality using Kolmogorov-Smirnov test and Shapiro-Wilk test. Comparisons between two groups for normally distributed numeric variables will be done using the paired t-test while for non-normally distributed numeric variables will be done by wilcoxon signed rank test. A p-value less than or equal to 0.05 will be considered statistically significant.
- Conditions
- Fibula / Surgery, Surgical Flaps, Computer-Aided Design, Mandibular Reconstruction* / Methods, Surgery, Computer-Assisted
- Being tested
- Computer guided placement of a stock plate pre-bent on a 3D printed model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided placement of a stock plate pre-bent on a 3D printed modelProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention will be modifying stock reconstruction plates to mimic patient specific plates in mandibular reconstruction with free fibula flaps Receives: Procedure: Computer guided placement of a stock plate pre-bent on a 3D printed model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear deviation of anatomical landmarks between postoperative outcome and preoperative virtual plan
Continuous numerical (mm)
Measured: immediately on the post op CT scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study startMay 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fibula / SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ghorab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672056
- Sponsor's protocol ID
- MohamedGhorabPHD
- Status last verified
- Apr 2023
- First submitted
- 30 Dec 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22447348Khatib 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.
PubMed 34958739Mascha 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.
PubMed 28965991Ghorab MO, Ellabban MA, Shindy MI, Beheiri MG, Zedan MH. Reverse-engineered stock plates as a "makeshift" patient-specific alternative: expanding the role of conventional plates in mandibular free fibula reconstruction. Oral Maxillofac Surg. 2026 Mar 17;30(1):55. doi: 10.1007/s10006-026-01528-6.
PubMed 41840235
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrator in Oral and Maxillofacial Surgery Department
- ClinicalTrials.gov ID
- NCT05672056
- Acronym / sponsor ID
- MohamedGhorabPHD
- Conditions
- Fibula / Surgery, Surgical Flaps, Computer-Aided Design, Mandibular Reconstruction* / Methods, Surgery, Computer-Assisted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim of the study:
The aim of the study is to evaluate the accuracy of mandibular reconstruction with free fibula flaps utilizing a novel design of resection and cutting guides based on reverse engineering stock plates into the VSP workflow.
Hypothesis:
The null hypothesis is that there is no significant difference between the postoperatively reconstructed mandible with free fibula flap and the virtually reconstructed mandible preoperatively
PICO:
Population (P): Patients with mandibular segmental defects who will receive free fibula flaps Intervention (I): Three-dimensionally printed guides based on VSP and reverse engineering for resection, predrilling of fixation holes, and shaping of the fibula segments Outcome (O): Accuracy of postoperative mandibular and fibular positions compared with the preoperative virtual surgical plan. In addition to patient reported satisfaction of functional and esthetic outcome. Finally, operative time will be recorded
Trial design:
validity study (pilot study)
Methods A) Participants, interventions \& outcomes
Study settings:
The patients will be recruited from the clinics of, the oral and maxillofacial surgery, Cairo University and the Head and neck unit in the National Cancer Institute.
Eligibility criteria:
Inclusion criteria
- 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
Exclusion criteria:
- Known allergies or sensitivities to materials such as titanium or acrylic or resin.
- Inability to return for follow up visits.
Post-operative accuracy evaluation:
- Post operative CT scans will be obtained within the first post operative month.
- The post operative DICOM will be segmented in software and the previously designed VSP model will be imported into the project and aligned by best fit algorithm to the unaffected portions of the skull.
- A color heat overlay map will be presented to evaluate the accuracy of reconstruction.
Several anatomical landmarks will be selected to calculate linear deviation measurements.
-Data collection methods Plans for assessment and collection of outcomes will be within the first post operative month and will be done by two assessors independently and inter-examiner calibration will be calculated through Kappa scoring as well as any differences will be solved by consensus. Data management Data will be recorded on diagnostic chart for each patient separately and will be stored with follow up photographs and clinical examination as well as patient's questionnaire. All data will be stored on laptop of the investigator, secured with a password with a backup on google drive and hard copy. The supervisors will have access on the data when needed. Statistical methods Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 24 (SPSS Inc., Chicago, IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Chi square test will be used for categorical data. Data will be explored for normality using Kolmogorov-Smirnov test and Shapiro-Wilk test. Comparisons between two groups for normally distributed numeric variables will be done using the paired t-test while for non-normally distributed numeric variables will be done by wilcoxon signed rank test. A p-value less than or equal to 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Computer guided placement of a stock plate pre-bent on a 3D printed modelThe intervention will be modifying stock reconstruction plates to mimic patient specific plates in mandibular reconstruction with free fibula flaps |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Known allergies or sensitivities to materials such as titanium or acrylic or resin.
- Inability to return for follow up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer guided placement of a stock plate pre-bent on a 3D printed modelWe 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. | Procedure or surgery | Intervention |
Primary outcome
Linear deviation of anatomical landmarks between postoperative outcome and preoperative virtual plan
Time frame: immediately on the post op CT scans
Continuous numerical (mm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Background: PubMed 22447348Ciocca 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.
- Background: PubMed 34958739Khatib 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.
- Background: PubMed 28965991Mascha 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.
- Derived from this study: PubMed 41840235Ghorab MO, Ellabban MA, Shindy MI, Beheiri MG, Zedan MH. Reverse-engineered stock plates as a "makeshift" patient-specific alternative: expanding the role of conventional plates in mandibular free fibula reconstruction. Oral Maxillofac Surg. 2026 Mar 17;30(1):55. doi: 10.1007/s10006-026-01528-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided placement of a stock plate pre-bent on a 3D printed model in people with Fibula / Surgery and Surgical Flaps, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear deviation of anatomical landmarks between postoperative outcome and preoperative virtual plan (time frame: immediately on the post op CT scans). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05672056, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.