NCT04860427

Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture

Trapezoidal Condylar Plate (TCP) Versus Two Miniplates in Treatment of Subcondylar Fracture

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Fracture of Condylar Process

Interventions

Type	Name	Description
DEVICE	trapezoidal condylar plate	trapezoidal condylar plate open reduction and fixation
DEVICE	two miniplates	two miniplates open reduction and fixation

Timeline

• Start date: 2019-06-10
• Primary completion: 2021-09-01
• Completion: 2021-09-15
• First posted: 2021-04-27
• Last updated: 2021-07-22

Locations

1 site across 1 country: Egypt