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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01487018
Other study ID # gongx31480528
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04836130 - Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique N/A
Completed NCT04719312 - Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture N/A
Not yet recruiting NCT03484676 - Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture N/A
Completed NCT03075384 - Treatment of Unilateral Complicated Zygomatic Complex Fractures Using Computer-Assisted Navigation System N/A
Recruiting NCT05438784 - Application of CAD-CAM Technology in Orbital Bone Reconstruction N/A
Completed NCT05381337 - A Method of Calculating the Shortest Incision for Internal Fixation of Zygomatic Arch Fracture N/A
Completed NCT05695872 - A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures N/A