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A clinical study of patients with fractures of the walls of the eye wherein a template manufactured using computer technology is used as a guide in surgeries for plating of the fractures.

Evaluation of Virtual image Assisted Custom Fabricated Surgical Jig as a guide to improve Surgical Outcomes of Open Reduction Internal Fixation in Patients with Unilateral Orbital Fractures- A Prospective Observational Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/11/021929
Enrollment
15
Registered
2019-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Surgical jig: Surgical jig is 3D printed and used as a guide for implant placement for reconstruction of orbital fractures. The opposite orbit serves as a normal reference for comparis

Sponsors

Department of Oral and Maxillofacial Surgery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients in the age group of 18 â?? 60 years. 2. Patients with unilateral orbital trauma with fractures of one or more orbital walls as confirmed with clinical findings and Computed tomography. 3. Patients with displaced orbital wall fractures with or without resultant bone loss. 4. Patients with unilateral orbital blow-out fractures. 5. Patients with other concomitant fractures of midface and mandible. 6. Patients who present with unilateral orbital trauma within 10 days of injury. 7. Patient willingness to participate in the study and come for follow up.

Exclusion criteria

Exclusion criteria: 1. Patients with bilateral orbital wall fractures or trauma as confirmed with Computed Tomography. 2. Patient with preinjury ocular findings like Cataract, Diabetic retinopathy, Blindness, Strabismus, Exophthalmos due to Thyroid disease, Graveâ??s disease, Glaucoma, Macular degeneration. 3. Pure ophthalmic injuries without orbital wall fractures. 4. Patients with history of uncontrolled diabetes mellitus, prolonged steroid therapy, compromised immunity and associated bone pathology. 5. Patients with orbital wall fractures with severe Bone loss needing bone grafting. 6. Patients who have been treated surgically previously for the same site. 7. Patients who are unwilling to participate in the study.

Design outcomes

Primary

MeasureTime frame
To Evaluate use of Virtual Image Assisted Custom Fabricated Surgical Jig as a guide to improve Surgical Outcomes of Open Reduction Internal Fixation in Patients with Unilateral Orbital fracturesTimepoint: 2 weeks

Secondary

MeasureTime frame
To evaluate and compare the pre and post-operative clinical ophthalmic findings and ophthalmological function following open reduction and internal fixation using custom fabricated surgical jig in unilateral orbital fractures of different patterns and severity in patients with the contralateral normal orbit.Timepoint: 2 weeks;To evaluate the precision of reduction by virtually comparing the post-operative orbital volume correction achieved by open reduction internal fixation using custom fabricated surgical jigs with the contralateral normal orbit.Timepoint: 2 weeks;To quantify and compare the orbital soft tissue volumetric changes in traumatized and contralateral normal side.Timepoint: 2 weeks;To quantify the spatial 3D volume of the bony orbit of the traumatized side and non-traumatized side using computed tomography.Timepoint: 2 weeks;To record the dimensions of the optic canal in traumatized and the contralateral normal orbitTimepoint: 2 weeks;To virtually compare and evaluate the discrepancy in orbital volume in spatial zones and define specific areas and direction of volumetric change in the traumatized orbit when compared with the normal contralateral side.Timepoint: 2 weeks

Countries

India

Contacts

Public ContactDr Usha Asnani

Department of Oral and Maxillofacial Surgery, Mahatma Gandhi Missions Dental College and Hospital

srivallis@hotmail.com9769088803

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026