A New Surgical Approach to Treat Medial or Low Condylar Fractures

Not Applicable

Completed

• Conditions: Fracture of Condylar Process
• Interventions: Procedure: the minor approach

• Registration Number: NCT01851031
• Lead Sponsor: West China College of Stomatology

Brief Summary

The aim of the study was to compare the new approach and the retromandibular approach, so that the therapeutic effect and the advantages of the new approach would be clear.

Detailed Description

Sixty patients (72 sides) with medial or low condylar fractures were treated with surgical intervention. Thirty-six patients (42 sides) were treated with minor parotid anterior approach, and the other 24 patients (30 sides) were treated with retromandibular approach. The data about the operations and complications were recorded. The follow-up periods were 3-12 months.

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2013-04-27
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-08
• Last Update Submitted: 2013-05-08
• Study First Posted: 2013-05-10
• Last Update Posted: 2013-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• (1)clinical and imaging diagnosis of medial or low condylar fractures
• (2)bone fragments that were obviously dislocated, that affected patients appearance and function, requiring surgical intervention
• (3)no previous surgical treatment

Exclusion Criteria

• (1)medial or low condylar fractures without obvious displacement
• (2)patients who had previously undergone unsuccessful surgery
• (3)the surgical site had traumatic scar, so the approach could be carried out on the original incision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the minor approach group	the minor approach	Thirty-six patients (the minor parotid anterior approach group) were treated with minor parotid anterior approach
control group	the minor approach	24 patients (control group) were treated with the retromandibular approach

Primary Outcome Measures

Name	Time	Method
the number of participants with facial nerve injury	from 3 months to 1 year after surgery	to explore whether the minor parotid anterior approach could prevent facial nerve injury.

Trial Locations

Locations (1)

West China College of Stomatology; 🇨🇳 Chengdu, Sichuan, China