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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigation Surgery | Experimental | 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. |
|
| Traditional Surgery | Active Comparator | To compare with the experimental arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigation Surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Zygomatic Symmetry | Measurement the zygomatic symmetry of postoperative CT scan | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy evaluation of CT image | Anatomic contour of pre-operation design affected side was superimposed on postoperative one. Discrepancy between preoperative simulation and postoperative result was calculated. | 1 month |
| Facial Symmetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Zhang, Professor | Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology | Beijing | 100081 | China |
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| ID | Term |
|---|---|
| D015051 | Zygomatic Fractures |
| D005146 | Facial Asymmetry |
| ID | Term |
|---|---|
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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|
| Traditional Surgery | Procedure | To compare with the experamental group. |
|
|
Facial symmetry on the Visual Analog Scale and three-dimensional camera
| 3 month |
| D009422 |
| Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012107 | Research Design |
| D008722 | Methods |