Back to resultsA New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor
Primary Purpose
Mandibular Fracture
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Condylar reductor
Sponsored by
About this trial
This is an interventional treatment trial for Mandibular Fracture
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
The experimental group
The control group
Arm Description
In this group, the condylar reductor was applied in the surgical treatment of mandibular condylar fractures.
In this group, traditional surgical instruments were applied in the surgical treatment of mandibular condylar fractures.
Outcomes
Primary Outcome Measures
intraoperative reduction time
Secondary Outcome Measures
Full Information
NCT ID
NCT02850861
First Posted
July 6, 2016
Last Updated
July 29, 2016
Sponsor
Junhui Cui
Collaborators
West China Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02850861
Brief Title
A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor
Official Title
A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Junhui Cui
Collaborators
West China Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The experimental group
Arm Type
Experimental
Arm Description
In this group, the condylar reductor was applied in the surgical treatment of mandibular condylar fractures.
Arm Title
The control group
Arm Type
No Intervention
Arm Description
In this group, traditional surgical instruments were applied in the surgical treatment of mandibular condylar fractures.
Intervention Type
Device
Intervention Name(s)
Condylar reductor
Intervention Description
A new surgical instrument was designed to assist the surgeons to perform condylar fracture reduction.
Primary Outcome Measure Information:
Title
intraoperative reduction time
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Liu, MD
Organizational Affiliation
West China Hospital of Stomotalogy
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.hxkq.org/
Description
The West China Hospital of Stomatology has long been ranked as one of the national top hospitals in China
Learn more about this trial
A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor
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