Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

NCT01487018 | Completed Phase 3 DMC

• 1 other identifier: gongx31480528
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Zygomatic Fractures

Keywords

Zygomatic Fractures; Surgery, Computer-Assisted; Facial Asymmetry

Outcome Measures

Primary Outcomes (1)

• Zygomatic Symmetry

  Measurement the zygomatic symmetry of postoperative CT scan

  1 month

Secondary Outcomes (2)

• Accuracy evaluation of CT image

  1 month

• Facial Symmetry

  3 month

Study Arms (2)

Navigation Surgery

EXPERIMENTAL

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

Traditional Surgery

ACTIVE COMPARATOR

To compare with the experimental arm.

Procedure: Traditional Surgery

Interventions

Navigation Surgery PROCEDURE

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.

Also known as: Computer-Aided Surgery, Surgical Navigation

Navigation Surgery

Traditional Surgery PROCEDURE

To compare with the experamental group.

Also known as: Control Group

Traditional Surgery

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

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

Beijing, 100081, China

Location

MeSH Terms

Conditions

Zygomatic Fractures; Facial Asymmetry

Interventions

Surgery, Computer-Assisted; Control Groups

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yi Zhang, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 7, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

CN (1)