Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture

Not Applicable

Not yet recruiting

• Conditions: Mandibular Fractures
• Interventions: Procedure: ORIF through transparotid approach; Procedure: ORIF through retroparotid approach

• Registration Number: NCT06333197
• Lead Sponsor: Assiut University

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).

Detailed Description

Several approaches have been used for condylar fracture including intraoral, preauricular, submandibular and retromandibular approaches.

The selection of the appropriate surgical approach for condylar neck fracture represents a controversy.

The purpose of this Study is to Compare the outcomes and effectiveness between the retromandibular transparotid approach and retromandibular retroparotid approach for treatment of Condylar Fracture of Mandible.

Study Timeline

• Study First Submitted: 2023-12-27
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Study Start: 2024-08-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• 1. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transparotid approch	ORIF through transparotid approach	Patients who diagnosed with extra capsular fracture of mandibular condyle will undergo Retromandibular transparotid approch
Retroparotid approch	ORIF through retroparotid approach	Patients who diagnosed with extra capsular fracture of mandibular condyle will undergo Retromandibular retroparotid approch

Primary Outcome Measures

Name	Time	Method
Facial nerve injury	Up to 6 months	Incidence of Facial Nerve Injury Following the Manoeuvre. ( Temporary or Permanent )
Operative time	Up to 3 hours	The duration of the operation

Secondary Outcome Measures

Name	Time	Method
Other Complication related to the Approach	Up to 6 Months	Salivary Fistula, Sialocele, Freys Syndrome
Fracture stability	Up to 3 Months	Measure the status of bone after reduction
Mouth opening	Up to 3 Months	Maximal inter incisor opening