Clinical trial NCT05438784: Application of CAD-CAM Technology in Orbital Bone Reconstruction
Official title: Comparison of Two Different Modalities for Orbital Reconstruction Based on CAD-CAM Technology: A Clinical Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orbital Bone Fracture
Maxillary Cyst
Maxillary Neoplasms
Zygomatic Fractures
Orbital Neoplasms
Facial Deformity
Keywords: Orbital bone reconstruction
zygomaticomaxillary complex fracture (ZMC)
patient specific implant
preformed plates
CAD-CAM
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 34
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: measurement of Changes in orbital bony volume
timeFrame: preoperative and one week and 6 months post-operative
Secondary outcomes:
measure: measurement of Changes in globe position in the bony orbit
timeFrame: preoperative and one week and 6 months post operative
measure: measurement of Changes in zygomaticomaxillary complex symmetry
timeFrame: preoperative and one week and 6 months post operative
Other outcomes:
measure: changes in ocular motility pre and post-operative
timeFrame: preoperative and one week ,one month ,3rd and 6th month post operative
measure: cost of the implant in US dollar
timeFrame: Through study completion, an average of 1 year
measure: adverse events
timeFrame: postoperative one week , 3rd and 6th moths postoperative
measure: changes in patient satisfaction using scoring system from 1 to 5
timeFrame: 1st, 3rd and 6th month post operative
measure: duration of surgery
timeFrame: intraoperative
measure: measurement of changes in visual acuity using A Snellen chart test
timeFrame: preoperative and one week ,one month ,3rd and 6th month post operative
measure: changes in aesthetic results using scoring system from 1 to 4
timeFrame: 1st, 3rd and 6th month post operative
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
affiliation: Sohag University
name: Kamal A Hassanein, Professor
role: STUDY_CHAIR
affiliation: Sohag University
name: Tarek A Ftohy, Ass. prof
role: STUDY_DIRECTOR
affiliation: Sohag University
name: Islam AA Amer, Ass. prof
role: STUDY_DIRECTOR
References:
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