Zygomatic Fractures Clinical Trial
Official title:
Evaluation of the Application of Point-to-Point Computer-Assisted Navigation for Mirroring-Reconstructing of Unilateral Posttraumatic Zygomatic Deformity: A Randomized Controlled Trial
Verified date | October 2015 |
Source | Peking University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics CommitteeChina: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | July 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology | Peking |
Lead Sponsor | Collaborator |
---|---|
Peking University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Zygomatic Symmetry | Measurement the zygomatic symmetry of postoperative CT scan | 1 month | No |
Secondary | 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 | No |
Secondary | Facial Symmetry | Facial symmetry on the Visual Analog Scale and three-dimensional camera | 3 month | No |
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