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Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture

A

Alexandria University

Status

Unknown

Conditions

Fracture of Condylar Process

Treatments

Device: trapezoidal condylar plate
Device: two miniplates

Study type

Interventional

Funder types

Other

Identifiers

NCT04860427
IRB NO 00010556-IORG 0008839

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • 1- Medically fit patients free from relevant conditions that contraindicate surgery.

    2- Patients with age ranged from 20-40 years old. 3- Patients suffering from displaced extracapsular mandibular subcondylar fracture indicated for open reduction including Difficulty of obtaining adequate occlusion by closed method, Radiological signs of the following

    1. Deviation of the fragment from the axis of the ascending ramus in medial or lateral direction more than 10°.(22)

    2. Shortening of the ascending ramus ≥ 2 mm measured from the roof of glenoid fossa to the inferior border of the ascending ramus of the mandible.(22)

    3. Dislocation of the condyle from the glenoid fossa.(48)

      Exclusion Criteria:

    1. Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems.

    2. Any absolute contraindication for surgery. 3. Patient with undisplaced condylar fractures that doesn't cause malocclusion or loss of facial heightening and can be treated conservatively.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups

Trapezoidal condylar plate
Active Comparator group
Description:
Trapezoidal condylar plate open reduction and internal fixation of subcondylar fractures
Treatment:
Device: trapezoidal condylar plate
two miniplates
Active Comparator group
Description:
two miniplates open reduction and internal fixation of subcondylar fractures
Treatment:
Device: two miniplates

Trial contacts and locations

1

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Central trial contact

mona oraby, ass. lect.; mohamed mekky, ass. lect.

Data sourced from clinicaltrials.gov

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