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Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture

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ClinicalTrials.gov Identifier: NCT04860427
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
mona oraby, Alexandria University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Fracture of Condylar Process Device: trapezoidal condylar plate Device: two miniplates Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trapezoidal Condylar Plate (TCP) Versus Two Miniplates in Treatment of Subcondylar Fracture
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. comparison of functional mandibular movement between the two groups [ Time Frame: preopertive, 1 week, 1month , 3 months , 6months ]
    the change mandibular movement in mm

  2. comparison of occlusion between the two groups [ Time Frame: preopertive, 1 week, 1month , 3 months , 6months ]
    the change in occlusion intercuspation assessed visually by the surgeon and by asking the patient

  3. comparison of helikmo index between the two groups [ Time Frame: preopertive, 1 week, 1month , 3 months , 6months ]
    the change in helikmo index score

  4. comparison in pain between the two groups [ Time Frame: 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)

  5. comparison in ramus height shortening between the two groups [ Time Frame: 1 day, 3 months, 6 months. ]
    radiographically: assess the adequacy of reduction by th change in ramus height in mm

  6. comparison in condylar angulation between the two groups [ Time Frame: 1 day, 3 months, 6 months. ]
    radiographically: assess the adequacy of reduction by measuring the change in condylar angulation

  7. bone density change comparison between the two groups [ Time Frame: 1 day postoperative, 1month and 3months ]
    assessment with CT in Hounsfield value measurements.


Secondary Outcome Measures :
  1. Transmasseteric Anteroparotid surgical approach [ Time Frame: 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.

  2. the stress on plates by using finite element analysis [ Time Frame: immediate postopertive ]
    stress values (Mpa) were obtained in this study for each of the two models during load application

  3. the displacement (micromotion) [ Time Frame: immediate postoperative ]
    the amount of vertical displacement induced around the fracture surface (µm)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04860427


Contacts
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Contact: mona oraby, ass. lect. 00201000775330 drmonasamy@gmail.com
Contact: mohamed mekky, ass. lect. 00201211332210 mastermekky@gmail.com

Locations
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Egypt
Mona Oraby Recruiting
Alexandria, Egypt, 25588
Contact: mona oraby, ass. lect.    01000775330    drmonasamy@gmail.com   
Sponsors and Collaborators
Alexandria University
Investigators
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Study Chair: nagy el prince, professor oral and maxillofacial surgery, alexanderia university
More Information
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Responsible Party: mona oraby, Assistant lecturer, oral and maxillofacial surgery department, Alexandria University
ClinicalTrials.gov Identifier: NCT04860427    
Other Study ID Numbers: IRB NO 00010556-IORG 0008839
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries