Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fracture of Condylar Process
• Intervention / Treatment: Device: trapezoidal condylar plate; Device: two miniplates

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mona oraby, ass. lect.; Phone Number: 00201000775330; Email: drmonasamy@gmail.com
• Study Contact Backup: Name: mohamed mekky, ass. lect.; Phone Number: 00201211332210; Email: mastermekky@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt, 25588
    • Recruiting
    • Mona Oraby
    • Contact: mona oraby, ass. lect.; Phone Number: 01000775330; Email: drmonasamy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Trapezoidal condylar plate; Trapezoidal condylar plate open reduction and internal fixation of subcondylar fractures	Device: trapezoidal condylar plate; trapezoidal condylar plate open reduction and fixation
Active Comparator: two miniplates; two miniplates open reduction and internal fixation of subcondylar fractures	Device: two miniplates; two miniplates open reduction and fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of functional mandibular movement between the two groups	the change mandibular movement in mm	preopertive, 1 week, 1month , 3 months , 6months
comparison of occlusion between the two groups	the change in occlusion intercuspation assessed visually by the surgeon and by asking the patient	preopertive, 1 week, 1month , 3 months , 6months
comparison of helikmo index between the two groups	the change in helikmo index score	preopertive, 1 week, 1month , 3 months , 6months
comparison in pain between the two groups	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)	preopertive, 1 week, 1month
comparison in ramus height shortening between the two groups	radiographically: assess the adequacy of reduction by th change in ramus height in mm	1 day, 3 months, 6 months.
comparison in condylar angulation between the two groups	radiographically: assess the adequacy of reduction by measuring the change in condylar angulation	1 day, 3 months, 6 months.
bone density change comparison between the two groups	assessment with CT in Hounsfield value measurements.	1 day postoperative, 1month and 3months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transmasseteric Anteroparotid surgical approach	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.	intraopertive
the stress on plates by using finite element analysis	stress values (Mpa) were obtained in this study for each of the two models during load application	immediate postopertive
the displacement (micromotion)	the amount of vertical displacement induced around the fracture surface (µm)	immediate postoperative

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Chair: nagy el prince, professor, oral and maxillofacial surgery, alexanderia university

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 15, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: IRB NO 00010556-IORG 0008839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No