Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT04860427
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2021-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture
Sponsor:
Alexandria University
Organization:
Study Overview
Official Title:
Trapezoidal Condylar Plate (TCP) Versus Two Miniplates in Treatment of Subcondylar Fracture
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment.
A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.
Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.
A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.
Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.
Detailed Description:
Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. It is the most controversial fractures regarding diagnosis and management.
For several years, closed reduction has been preferred over open reduction to avoid surgical complications. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment.
A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.
Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.
Aim: Our aim in this study is to assess the use of TCP in the subcondylar fracture in comparison to the use of conventional two miniplates method.
Materials and methods: This prospective randomized clinical trial will enroll 20 patients with subcondylar fracture indicated for open reduction and internal fixation. Group A will undergo fixation with TCP and group B will have two miniplates fixation. Both groups will have Transmasseteric Anteroparotid approach.
Results: The results of the two groups will be compared clinically and radiographically.
Keywords: Subcondylar fracture, Trapezoidal condylar plate, two miniplates, open treatment for condyle, geometric subcondylar plates, transmasseteric anteroparotid approach.
For several years, closed reduction has been preferred over open reduction to avoid surgical complications. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment.
A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.
Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.
Aim: Our aim in this study is to assess the use of TCP in the subcondylar fracture in comparison to the use of conventional two miniplates method.
Materials and methods: This prospective randomized clinical trial will enroll 20 patients with subcondylar fracture indicated for open reduction and internal fixation. Group A will undergo fixation with TCP and group B will have two miniplates fixation. Both groups will have Transmasseteric Anteroparotid approach.
Results: The results of the two groups will be compared clinically and radiographically.
Keywords: Subcondylar fracture, Trapezoidal condylar plate, two miniplates, open treatment for condyle, geometric subcondylar plates, transmasseteric anteroparotid approach.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: