Accuracy of Virtual Surgical Planning and Patient Specific Implants in Craniomaxillofacial Reconstruction

Hams Hamed Abdelrahman15 enrolled

Overview

The sample will consist of 10 patients who will need reconstruction of craniomaxillofacial deformities and defects. The patients will be operated in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt. All patients will be assessed clinically and radiographically using computed tomography (CT) then virtual surgical planning and custom made patient specific implant will be manufactured. Post-operative clinical evaluation will be done and radiographic evaluation of all patients will be done by CT scan

The primary outcome of the study is to evaluate the accuracy of virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction based on radiographic measurements to calculate the angulation deviations of anatomic landmarks between the pre-operative virtual plan and the post-operative actual surgical outcome. The secondary outcome is long term follow up of the patients clinically and radiographically regarding aesthetics, quality of life and post-operative complications.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Craniofacial Surgery Virtual Surgical Planning

Interventions

virtual surgical planning and patient specific implants in craniomaxillofacial reconstructionPROCEDURE

Image acquisition by computed tomography (CT slice thickness 1 mm or less) + laser scanning of patient models. Virtual surgical planning and design of patient specific implants. Patient specific implants manufacturing (milling technique) and 3D printing of surgical guides and fit models.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 47 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Reconstruction of craniofacial, midface, and mandibular bony defects and deformities secondary to: * Trauma. * Tumor resection (either by immediate or delayed reconstruction). * Complex congenital and dentofacial deformities. Exclusion Criteria: * Patients with special needs. * Medically compromised patients who are not fit for surgery. * Irradiated patients.

Outcomes

Primary Outcomes

Distance deviation

the accuracy of reconstruction, defined as linear deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans

Time frame: Immediate post operative

Angular deviation

the accuracy of reconstruction, defined as angulation deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans

Time frame: Immediate post operative

Secondary Outcomes

Change in post operative aesthetic results of surgery

aesthetic scale from zero to 5 * 5 points - changes are not visually noticeable. * 4 points - changes in appearance are barely noticeable and do not affect the patient's quality of life. * 3 points - aesthetic deficit that does not require surgical correction. * 2 points - aesthetic defects require minor surgical corrections in the postoperative period. * 1 point - significant aesthetic defects require serious (often multi-stage surgical correction). * 0 points - the presence of severe aesthetic defects that cannot be eliminated.

Time frame: 1 week, 4 weeks, 8 weeks, and 6 months

change in Quality of Life (QOL)

Scores as follow 0 = much better. 1. = better. 2. = the same. 3. = worse. 4. = much worse