Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture

NCT06333197 | Not Yet Recruiting

• 1 other identifier: Mandibular condylar fracture
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The condylar region is the most frequent anatomical site for mandibular fractures . Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ).

Conditions

Mandibular Fractures

Keywords

Mandibular Condylar fracture; Approaches for mandibular fractures; Transparotid; Retromandibular; Comparative study; Retroparotid

Outcome Measures

Primary Outcomes (2)

• Facial nerve injury

  Incidence of Facial Nerve Injury Following the Manoeuvre. ( Temporary or Permanent )

  Up to 6 months

• Operative time

  The duration of the operation

  Up to 3 hours

Secondary Outcomes (3)

• Fracture stability

  Up to 3 Months

• Mouth opening

  Up to 3 Months

• Other Complication related to the Approach

  Up to 6 Months

Study Arms (2)

transparotid approch

EXPERIMENTAL

Patients who diagnosed with extra capsular fracture of mandibular condyle will undergo Retromandibular transparotid approch

Procedure: ORIF through transparotid approach

Retroparotid approch

EXPERIMENTAL

Patients who diagnosed with extra capsular fracture of mandibular condyle will undergo Retromandibular retroparotid approch

Procedure: ORIF through retroparotid approach

Interventions

ORIF through transparotid approach PROCEDURE

The Retromandibular Transparotid approach is a surgical method used to access structures in the parotid gland region by making an incision behind the mandible.

transparotid approch

ORIF through retroparotid approach PROCEDURE

The Retromandibular Retroparotid approach, also known as the Modified Blair Incision, is a surgical technique used to access structures within the parotid gland region by creating an incision behind the mandible and extending it into the parotid region.

Also known as: ORIF through the Modified Blair Incision

Retroparotid approch

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery.

You may not qualify if:

• \. Open Laceration in the condylar region. 2. Concomitant traumatic Facial Nerve injury. 3. Previous Surgery in Retromandibular region. 4. Severe Obese patients 5. Patients Refusing Surgery.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Central Study Contacts

Mustafa Mahmoud Hussien

CONTACT

+201015750092; Urfavdash@gmail.com

Diaa El-dein Saber, PHD degree

CONTACT

+201007967946; diaasaber@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at general surgery department

Model Details: ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery.

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: March 27, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07