Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Peking University
Sponsor:
Information provided by (Responsible Party):
Gong Xi, Peking University
ClinicalTrials.gov Identifier:
NCT01487018
First received: November 29, 2011
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Zygomatic Fractures
Procedure: Navigation Surgery
Procedure: Traditional Surgery
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • Zygomatic Symmetry [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Measurement the zygomatic symmetry of postoperative CT scan


Secondary Outcome Measures:
  • Accuracy evaluation of CT image [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Anatomic contour of pre-operation design affected side was superimposed on postoperative one. Discrepancy between preoperative simulation and postoperative result was calculated.

  • Facial Symmetry [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Facial symmetry on the Visual Analog Scale and three-dimensional camera


Estimated Enrollment: 78
Study Start Date: December 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Names:
  • Computer-Aided Surgery
  • Surgical Navigation
Active Comparator: Traditional Surgery
To compare with the experimental arm.
Procedure: Traditional Surgery
To compare with the experamental group.
Other Name: Control Group

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

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487018

Contacts
Contact: Yi Zhang, Professor 0086-10-82195624 zhangyi2000@263.net
Contact: Xi Gong, Postgraduate 0086-150130426 gongx31480528@163.com

Locations
China
Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology Recruiting
Peking, China, 100081
Contact: Xi Gong, Master    0086-15201304426    gongx31480528@163.com   
Contact: Yang He, Doctor    0086-18911802149    fridaydust1983@gmail.com   
Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Yi Zhang, Professor Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology
  More Information

No publications provided

Responsible Party: Gong Xi, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Peking University
ClinicalTrials.gov Identifier: NCT01487018     History of Changes
Other Study ID Numbers: gongx31480528
Study First Received: November 29, 2011
Last Updated: November 12, 2013
Health Authority: China: Ethics Committee
China: Ministry of Health

Keywords provided by Peking University:
Zygomatic Fractures
Surgery, Computer-Assisted
Facial Asymmetry

Additional relevant MeSH terms:
Fractures, Bone
Zygomatic Fractures
Wounds and Injuries
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Skull Fractures

ClinicalTrials.gov processed this record on July 31, 2014