Application of CAD-CAM Technology in Orbital Bone Reconstruction

H

Hatem Adel Aboelhassan

Status

Enrolling

Conditions

Maxillary Cyst
Orbital Neoplasms
Zygomatic Fractures
Facial Deformity
Maxillary Neoplasms
Orbital Bone Fracture

Treatments

Procedure: orbital bone reconstruction with patient specific titanium implant
Procedure: orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model

Study type

Interventional

Funder types

Other

Identifiers

NCT05438784
Soh-Med-22-06-18

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 2 patient groups

Group A (patient specific titanium implant)
Active Comparator group
Description:
(reconstruction with patient specific titanium implant)
Treatment:
Procedure: orbital bone reconstruction with patient specific titanium implant
Group B (preformed plate bended on stereolithographic model)
Active Comparator group
Description:
(reconstruction with preformed titanium plate preoperatively bended on stereolithographic model)
Treatment:
Procedure: orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model

Trial contacts and locations

1

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Central trial contact

Hatem A Abo El Hassan El Shazly, MMed

Data sourced from clinicaltrials.gov

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