Clinical trial NCT01487018: Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Zygomatic Fractures
Keywords: Zygomatic Fractures
Surgery, Computer-Assisted
Facial Asymmetry
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 103
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Zygomatic Symmetry
timeFrame: 1 month
Secondary outcomes:
measure: Accuracy evaluation of CT image
timeFrame: 1 month
measure: Facial Symmetry
timeFrame: 3 month
Other outcomes:
Locations:
city: Peking
country: China
facility: Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology
Study officials:
affiliation: Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology
name: Yi Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: