Treatment of Diacapitular Condylar Fractures
A Modified Preauricular Approach to Treat Diacapitular Condylar Fractures: The Supratemporalis Approach
1 other identifier
observational
1
0 countries
N/A
Brief Summary
A new surgical approach, denoted as the supratemporalis approach, was designed to treat diacapitular condylar fractures of the mandibular condyle.This approach prevented facial nerve injury and did not increase the frequency of other complications. Therefore, the investigators suggest this surgical procedure as a routine and safe approach to diacapitular condylar fractures, which can also be applied to temporomandibular joint(TMJ)and to the zygomatic arch.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2014
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 3, 2015
CompletedFirst Posted
Study publicly available on registry
June 9, 2015
CompletedOctober 25, 2017
October 1, 2017
9 months
June 3, 2015
October 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change from facial nerve function at 24 hours postoperatively
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
24 hours
Change from facial nerve function at 1 week postoperatively
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
1 week
Change from facial nerve function at 3 months postoperatively
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
3 months
Change from facial nerve function at 6 months postoperatively
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
6 months
Change from facial nerve function at 12 months postoperatively
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
12 months
Study Arms (1)
the preauricular approach
A classic preauricular incision was used to treat diacapitular condylar fractures
Interventions
The supratemporalis approach was applied in treatment of diacapitular condylar fractures
Eligibility Criteria
patients with diacapitular condylar fractures
You may qualify if:
- clinical and radiographical diagnosis of DFs;
You may not qualify if:
- condylar fractures with undisplaced fractures;
- Fractures without the reduction of the condylar height;
- A obvious scar at the temporal region, affecting the placement of the original incision.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hui Lilead
- West China College of Stomatologycollaborator
Related Publications (32)
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PMID: 15346360RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lei Li, DMD
Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 3, 2015
First Posted
June 9, 2015
Study Start
August 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
October 25, 2017
Record last verified: 2017-10