A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor

July 29, 2016 updated by: Junhui Cui
In condylar fracture surgery, reduction is the most difficult step and the key factor which determined the postoperative outcome. Therefore, the aim of this study is to develop a new instrument, which the investigators call condylar redactor, to assist the surgeon to reduct the condylar segments effectively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this prospective cohort study, it involved condylar fractures patients who were received surgical treatment from January 2014 to June 2016. Patients in the experimental group were treated with the condylar reductor, and patients in the control group were treated with the traditional surgical instruments. The primary outcome variable was reduction time and reduction rate. The continuity correction X2 and test student t test were used.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged 18-60 with mandibular condylar fractures were treated in Oral and maxillofacial surgery department, West China hospital of stomatology, China from January 2014 to January 2016.

Exclusion Criteria:

  • patients refused to participate in the clinical trial;
  • condylar fracture dislocation was not obvious, conservative treatment can be used;
  • mandibular condylar comminuted fracture;
  • mandibular condyle need to be reconstructed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The experimental group
In this group, the condylar reductor was applied in the surgical treatment of mandibular condylar fractures.
Device: Condylar reductor
A new surgical instrument was designed to assist the surgeons to perform condylar fracture reduction.
No Intervention: The control group
In this group, traditional surgical instruments were applied in the surgical treatment of mandibular condylar fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intraoperative reduction time
Time Frame: intraoperative
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Junhui Cui

Collaborators

West China Hospital

Investigators

  • Study Director: Lei Liu, MD, West China Hospital of Stomotalogy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCH-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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