Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture

Not Applicable

• Conditions: Fracture of Condylar Process
• Interventions: Device: trapezoidal condylar plate; Device: two miniplates

• Registration Number: NCT04860427
• Lead Sponsor: Alexandria University

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.

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.

Study Timeline

• Study Start: 2019-06-10
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-27
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trapezoidal condylar plate	trapezoidal condylar plate	Trapezoidal condylar plate open reduction and internal fixation of subcondylar fractures
two miniplates	two miniplates	two miniplates open reduction and internal fixation of subcondylar fractures

Primary Outcome Measures

Name	Time	Method
comparison in pain between the two groups	preopertive, 1 week, 1month	the change in pain value with Visual analogue Scale With a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain or discomfort)
bone density change comparison between the two groups	1 day postoperative, 1month and 3months	assessment with CT in Hounsfield value measurements.
comparison of functional mandibular movement between the two groups	preopertive, 1 week, 1month , 3 months , 6months	the change mandibular movement in mm
comparison of helikmo index between the two groups	preopertive, 1 week, 1month , 3 months , 6months	the change in helikmo index score
comparison in ramus height shortening between the two groups	1 day, 3 months, 6 months.	radiographically: assess the adequacy of reduction by th change in ramus height in mm
comparison of occlusion between the two groups	preopertive, 1 week, 1month , 3 months , 6months	the change in occlusion intercuspation assessed visually by the surgeon and by asking the patient
comparison in condylar angulation between the two groups	1 day, 3 months, 6 months.	radiographically: assess the adequacy of reduction by measuring the change in condylar angulation

Secondary Outcome Measures

Name	Time	Method
Transmasseteric Anteroparotid surgical approach	intraopertive	To evaluate the Transmasseteric Anteroparotid surgical approach for the subcondylar fracture regarding the time taken to reach the fracture line and convenience of the approach.
the stress on plates by using finite element analysis	immediate postopertive	stress values (Mpa) were obtained in this study for each of the two models during load application
the displacement (micromotion)	immediate postoperative	the amount of vertical displacement induced around the fracture surface (µm)

Trial Locations

Locations (1)

Mona Oraby; 🇪🇬 Alexandria, Egypt