Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487018
• Other study ID #: gongx31480528
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2011
• Last updated: October 20, 2015
• Start date: December 2011
• Est. completion date: July 2015

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Zygomatic Fractures

Intervention

Procedure:
• 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
To compare with the experamental group.

Locations

Country	Name	City	State
China	Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology	Peking

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

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