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Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

Primary Purpose

Zygomatic Fractures

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Navigation Surgery

Traditional Surgery

About this trial

This is an interventional treatment trial for Zygomatic Fractures focused on measuring Zygomatic Fractures, Surgery, Computer-Assisted, Facial Asymmetry

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

post-traumatic unilateral deformities of the zygomaticomaxillary complex
The interval after the primary injury should be more than 21 days
Meet the operation indication
Voluntarily join this study with informed consents

Exclusion Criteria:

Obviously asymmetric of craniofacial structure
Poor compliance of patient
Any other condition that do not fit to participate in the study

Sites / Locations

Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Navigation Surgery

Traditional Surgery

Arm Description

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.

To compare with the experimental arm.

Outcomes

Primary Outcome Measures

Zygomatic Symmetry

Measurement the zygomatic symmetry of postoperative CT scan

Secondary Outcome Measures

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.

Facial Symmetry

Facial symmetry on the Visual Analog Scale and three-dimensional camera

Full Information

NCT ID

NCT01487018

First Posted

November 29, 2011

Last Updated

October 20, 2015

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT01487018

Brief Title

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

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Zygomatic Fractures

Keywords

Zygomatic Fractures, Surgery, Computer-Assisted, Facial Asymmetry

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Navigation Surgery

Arm Type

Experimental

Arm Description

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.

Arm Title

Traditional Surgery

Arm Type

Active Comparator

Arm Description

To compare with the experimental arm.

Intervention Type

Procedure

Intervention Name(s)

Navigation Surgery

Other Intervention Name(s)

Computer-Aided Surgery, Surgical Navigation

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Traditional Surgery

Other Intervention Name(s)

Control Group

Intervention Description

To compare with the experamental group.

Primary Outcome Measure Information:

Title

Zygomatic Symmetry

Description

Measurement the zygomatic symmetry of postoperative CT scan

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Accuracy evaluation of CT image

Description

Anatomic contour of pre-operation design affected side was superimposed on postoperative one. Discrepancy between preoperative simulation and postoperative result was calculated.

Time Frame

1 month

Title

Facial Symmetry

Description

Facial symmetry on the Visual Analog Scale and three-dimensional camera

Time Frame

3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: post-traumatic unilateral deformities of the zygomaticomaxillary complex The interval after the primary injury should be more than 21 days Meet the operation indication Voluntarily join this study with informed consents Exclusion Criteria: Obviously asymmetric of craniofacial structure Poor compliance of patient Any other condition that do not fit to participate in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Zhang, Professor

Organizational Affiliation

Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology

City

Peking

ZIP/Postal Code

100081

Country

China

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

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