Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

Phase 3

Completed

• Conditions: Zygomatic Fractures
• Interventions: Procedure: Navigation Surgery; Procedure: Traditional Surgery

• Registration Number: NCT01487018
• Lead Sponsor: Peking University

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.

Study Timeline

• Study First Submitted: 2011-11-29
• Study Start: 2011-12
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Primary Completion: 2015-03
• Study Completion: 2015-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Navigation Surgery	Navigation 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.
Traditional Surgery	Traditional Surgery	To compare with the experimental arm.

Primary Outcome Measures

Name	Time	Method
Zygomatic Symmetry	1 month	Measurement the zygomatic symmetry of postoperative CT scan

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology; 🇨🇳 Peking, China