Zygomatic Fractures
Conditions
Keywords
Zygomatic Fractures, Surgery, Computer-Assisted, Facial Asymmetry
Brief summary
Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge, even to the skilled surgeon. However, the development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, the investigators would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.
Detailed description
Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge. Even to the skilled surgeon, over-or underestimation of the displacement is likely to occur, leading to an unsatisfactory result caused by over- or undercorrection.However,The development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, we would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.
Interventions
PROCEDURENavigation Surgery
To evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.
PROCEDURETraditional Surgery
To compare with the experamental group.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. post-traumatic unilateral deformities of the zygomaticomaxillary complex 2. The interval after the primary injury should be more than 21 days 3. Meet the operation indication 4. Voluntarily join this study with informed consents
Exclusion criteria
1. Obviously asymmetric of craniofacial structure 2. Poor compliance of patient 3. Any other condition that do not fit to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zygomatic Symmetry | 1 month | Measurement the zygomatic symmetry of postoperative CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy evaluation of CT image | 1 month | Anatomic contour of pre-operation design affected side was superimposed on postoperative one. Discrepancy between preoperative simulation and postoperative result was calculated. |
| Facial Symmetry | 3 month | Facial symmetry on the Visual Analog Scale and three-dimensional camera |
Countries
China
Outcome results
None listed