AzTrials
AzTrials

Orbital Bone FractureCAD-CAMNCT05438784

Application of CAD-CAM Technology in Orbital Bone Reconstruction

A study testing orbital bone reconstruction with patient specific titanium implant and orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model in people with Orbital Bone Fracture and Maxillary Cyst, run by Hatem Adel Aboelhassan at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Reconstruction of orbital defects resulting after trauma; tumor resection; maxillary cyst; craniofacial anomalies and sequestrated bone…. etc., has been a challenging issue over the years and this owing to the complicated anatomy of orbit. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
orbital bone reconstruction with patient specific titanium implant and orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteEgypt
Study dates
1 Jun 2022to 1 Jun 2024
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • fracture of the orbital floor and/or medial wall and/or lateral wall.
  • complex fracture of the zygomatic bone (those affecting orbital volume).
  • Old orbital fractures on either side causing enophthalmos, diplopia, cosmetic asymmetry.
  • Periorbital neoplasm affecting orbital volume and need surgical resection

Who cannot join

  • injury to the globe that restricts surgical reconstruction.
  • neurological diseases with influence on eye motility or sight.
  • Patients with special needs.
  • Medically compromised patients who are not fit for surgery.
  • Patients refused participation in this study.

Trial locations and contacts

1 site in 1 country.

Hatem A Abo El Hassan El Shazly, MMed contact

+201002760859 ext. +201114455343

hatem_adel_post@med.sohag.edu.eg

Egypt1 site, 1 recruiting

  • Sohag faculty of medicine

    Sohag, 82524

    Sohag F Medicine, +2093602963, portal@med.sohag.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Comparison of Two Different Modalities for Orbital Reconstruction Based on CAD-CAM Technology: A Clinical Randomized Trial

Reconstruction of orbital defects resulting after trauma; tumor resection; maxillary cyst; craniofacial anomalies and sequestrated bone…. etc., has been a challenging issue over the years and this owing to the complicated anatomy of orbit. Inaccurate orbital reconstruction may lead to devastating cosmetic and functional complications. Titanium mesh for orbital reconstruction has now become "probably" the most popular material for orbital wall reconstruction worldwide. Innovation of CAD-CAM technology and its application in maxillofacial surgery will markedly improve the surgical outcome. This study will assess the accuracy of orbital reconstruction using CAD-CAM technology and to compare two different modalities for orbital reconstruction based on this technology.

Read the detailed description

This study will be a prospective cohort study. It will include patients treated with the custom-made implants for orbital blow out fractures, ZMC fractures or tumors. The sample will consist of 34 patients who will need orbital reconstruction and will be operated in Maxillofacial, Head and Neck Unit, General Surgery Department, Faculty Of Medicine, Sohag University, Egypt. The patients will be randomly divided into two groups, group (A) reconstructed with patient specific implant and group (B) reconstructed with preformed plate preoperatively bended on stereolithographic model. The reconstructive outcomes are assessed by clinical and ophthalmological examinations and accuracy analysis by comparing the preoperative and postoperative multi slice computed tomography data. All patients will be assessed clinically, ophthalmologically, and radiographically using computed tomography (CT) then virtual surgical planning and custom-made patient implant will be manufactured. Post-operative clinical evaluation will be done, and radiographic evaluation of all patients will be done by CT scan within one week and 6 months after the procedure. comparing data of the two groups will be done using appropriate methods.

Being tested
orbital bone reconstruction with patient specific titanium implant, orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model
Keywords
Orbital bone reconstruction, zygomaticomaxillary complex fracture (ZMC), patient specific implant, preformed plates, CAD-CAM
Medical subject headings
Orbital Fractures, Maxillary Neoplasms, Zygomatic Fractures, Orbital Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • orbital bone reconstruction with patient specific titanium implantProcedure or surgery

    orbital defects reconstruction will be virtually planned by software and a patient specific titanium implant will be manufactured using milling technique depending on CAD-CAM technology

  • orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic modelProcedure or surgery

    orbital defects reconstruction will be virtually planned by software and a reconstructed stereolithographic model will be 3D printed and used for preoperatively bending of preformed titanium implant.

Study groups in NCT05438784
Study groupRoleWhat they receive
Group A (patient specific titanium implant)Active comparator(reconstruction with patient specific titanium implant)
Receives: Procedure: orbital bone reconstruction with patient specific titanium implant
Group B (preformed plate bended on stereolithographic model)Active comparator(reconstruction with preformed titanium plate preoperatively bended on stereolithographic model)
Receives: Procedure: orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. measurement of Changes in orbital bony volume

    pre and post operative reconstructed orbit volume will be measured using multi slice computed tomography (MSCT) image loaded on software and compared with preoperative and with healthy non affected orbit

    Measured: preoperative and one week and 6 months post-operative

Secondary outcomes (2)

  1. measurement of Changes in globe position in the bony orbit

    pre and post operative measurement of globe position within the bony orbit using MSCT image loaded on software and comparing measures with preoperative and with healthy non affected orbit

    Measured: preoperative and one week and 6 months post operative

  2. measurement of Changes in zygomaticomaxillary complex symmetry

    in patients with associated ZMC affection, symmetry with the healthy side and prominence of the zygomatic eminence will be measured using MSCT image loaded on software and compared with preoperative and with healthy non affected ZMC

    Measured: preoperative and one week and 6 months post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2022
  2. Study start1 Jun 2022
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
the participants are assigned to two groups randomly A and B and receive two different intervention modality throughout the study and the results will be compared between the two groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05438784
Sponsor's protocol ID
Soh-Med-22-06-18
Acronym
CAD-CAM
Status last verified
Jun 2022
First submitted
21 Jun 2022
Last updated
30 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Abbate V, Iaconetta G, Califano L, Pansini A, Bonavolonta P, Romano A, Salzano G, Somma T, D'Andrea L, Dell'Aversana Orabona G. Self-Made Rapid Prototyping Technique for Orbital Floor Reconstruction: Showcases for Technical Description. J Craniofac Surg. 2019 Oct;30(7):2106-2110. doi: 10.1097/SCS.0000000000006004.

    PubMed 31513039

  • Zimmerer RM, Ellis E 3rd, Aniceto GS, Schramm A, Wagner ME, Grant MP, Cornelius CP, Strong EB, Rana M, Chye LT, Calle AR, Wilde F, Perez D, Tavassol F, Bittermann G, Mahoney NR, Alamillos MR, Basic J, Dittmann J, Rasse M, Gellrich NC. A prospective multicenter study to compare the precision of posttraumatic internal orbital reconstruction with standard preformed and individualized orbital implants. J Craniomaxillofac Surg. 2016 Sep;44(9):1485-97. doi: 10.1016/j.jcms.2016.07.014. Epub 2016 Jul 21.

    PubMed 27519662

  • Felding UNA. Blowout fractures - clinic, imaging and applied anatomy of the orbit. Dan Med J. 2018 Mar;65(3):B5459.

    PubMed 29510812

  • Mustafa SF, Evans PL, Bocca A, Patton DW, Sugar AW, Baxter PW. Customized titanium reconstruction of post-traumatic orbital wall defects: a review of 22 cases. Int J Oral Maxillofac Surg. 2011 Dec;40(12):1357-62. doi: 10.1016/j.ijom.2011.04.020. Epub 2011 Aug 31.

    PubMed 21885249

  • Raisian S, Fallahi HR, Khiabani KS, Heidarizadeh M, Azdoo S. Customized Titanium Mesh Based on the 3D Printed Model vs. Manual Intraoperative Bending of Titanium Mesh for Reconstructing of Orbital Bone Fracture: A Randomized Clinical Trial. Rev Recent Clin Trials. 2017;12(3):154-158. doi: 10.2174/1574887112666170821165206.

    PubMed 28828975

  • Sugar AW, Kuriakose M, Walshaw ND. Titanium mesh in orbital wall reconstruction. Int J Oral Maxillofac Surg. 1992 Jun;21(3):140-4. doi: 10.1016/s0901-5027(05)80780-5.

    PubMed 1640125

  • Bly RA, Chang SH, Cudejkova M, Liu JJ, Moe KS. Computer-guided orbital reconstruction to improve outcomes. JAMA Facial Plast Surg. 2013 Mar 1;15(2):113-20. doi: 10.1001/jamafacial.2013.316.

    PubMed 23306963

  • Longeac M, Depeyre A, Pereira B, Barthelemy I, Pham Dang N. Virtual surgical planning and three-dimensional printing for the treatment of comminuted zygomaticomaxillary complex fracture. J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):386-390. doi: 10.1016/j.jormas.2020.05.009. Epub 2020 May 18.

    PubMed 32439600

  • Scolozzi P. Applications of 3D orbital computer-assisted surgery (CAS). J Stomatol Oral Maxillofac Surg. 2017 Sep;118(4):217-223. doi: 10.1016/j.jormas.2017.05.007. Epub 2017 Jun 19.

    PubMed 28642192

Questions about this trial

What is this clinical trial studying?

A study testing orbital bone reconstruction with patient specific titanium implant and orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model in people with Orbital Bone Fracture and Maxillary Cyst, run by Hatem Adel Aboelhassan 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 4 inclusion and 5 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 30 Jun 2022. 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?

Contact Hatem A Abo El Hassan El Shazly, MMed (+201002760859 ext. +201114455343, hatem_adel_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measurement of Changes in orbital bony volume (time frame: preoperative and one week and 6 months post-operative). 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 NCT05438784, which also lists 9 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 30 Jun 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in