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Custom prebending on 3D model in compare to intraoperative bending of titanium mesh for healing of orbital bone fracture in adult

Custom prebending on 3D model in compare to intraoperative bending of titanium mesh for healing of orbital bone fracture in adult Patient-specific 3D printed template vs. intraoperative bending of titanium mesh for orbital reconstruction

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017042633094N1
Enrollment
10
Registered
2017-04-26
Start date
2016-05-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture of orbital floor. Fracture of orbital floor

Interventions

Intervention 1: Control: One week after trauma a preoperative CT scan of orbital bone is taken then the titanium mesh is shaped manually by experienced surgeon during the operation. The orbital wall i
Treatment - Devices
Control: One week after trauma a preoperative CT scan of orbital bone is taken then the titanium mesh is shaped manually by experienced surgeon during the operation. The orbital wall is dissected in p
Intervention: In this group, one week after trauma the patients undergo surgery in which preoperative CT scan is performed to create 3D reconstruction of affected and unaffected eyes. Then, a 3D print

Sponsors

Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: orbital bone fracture with at least 2 mm enophthalmous; vertical dystopia; diplopia. Exclusion criteria: patients who not interested to participate in the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Enophthalmos. Timepoint: baseline, 1 week, 1 month and 3 months after surgery. Method of measurement: Displacement of the globe and it was measured by exophthalmometer.

Secondary

MeasureTime frame
Vertical Dystopia. Timepoint: baseline, 1 week, 1 month and 3 months after surgery. Method of measurement: Vertical orbital dystopia was defined as vertical displacement of the globe and it was measured in compare to upper orbital rim and horizontal mid-pupillary line in the sitting position.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZeinab Shajirat

Ahvaz Jundishapur University of Medical Sciences

zeinab.shajirat@gmail.com+98 61 3221 6504

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026