Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

Not Applicable

Completed

• Conditions: Mandibular Fractures
• Interventions: Procedure: Open Reduction & Internal Fixation; Procedure: Closed Reduction & External Fixation

• Registration Number: NCT03494309
• Lead Sponsor: King Edward Medical University

Brief Summary

Patients with mandibular sub-condylar fractures underwent either either open reduction with internal fixation (ORIF) or closed reduction with external fixation (CREF) and were followed up for 6 months to assess treatment adequacy with the hypothesis that ORIF is superior to CREF.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-01
• Primary Completion: 2015-11-15
• Study Completion: 2015-11-15
• Study First Submitted: 2018-03-24
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-10
• Last Update Submitted: 2018-04-10
• Study First Posted: 2018-04-11
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age 16-60 years
• Displaced Mandibular Subcondylar Fractures(MCFs) irrespective of multiple mandibular fractures.

Exclusion Criteria

• Bilateral MCFs
• MCF with mid-facial fractures
• Insufficient bilateral dentition
• Medically unfit for surgery
• Old healed mandibular fractures
• History of previous mandibular surgery for the same indication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORIF	Open Reduction & Internal Fixation	Open Reduction \& Internal Fixation
CREF	Closed Reduction & External Fixation	Closed Reduction \& External Fixation

Primary Outcome Measures

Name	Time	Method
Mouth Opening	6 months	Mouth Opening shall be determined by measuring the maximal distance between the edges of upper and lower incisors with fully opened mouth; the measurement shall be made in millimeters (mm) using vernier caliper and mouth opening of 35 mm or more shall be classified as "adequate"
Occlusion	6 months	Occlusion shall be determined by maximum "inter-cuspation" as observed by the surgeon and patient self-reporting and will be classified as fine or deranged.

Secondary Outcome Measures

Name	Time	Method
Complications	6 months	The frequency of complications with either mode of treatment shall be recorded
Cost-Effectiveness	6 months	Cost-Effectiveness shall be determined as the ratio of the cost of treatment and achievement of both adequate mouth opening and fine occlusion.; The cost of treatment shall include the cost of surgical items (wires, elastics, arch bars, plates, screws etc), cost of anesthesia and surgery, cost of hospital stay and cost of follow up.
Patient Satisfaction	6 months	Participants shall be requested to report their satisfaction after treatment with regards to ease of chewing, mouth opening \& closing and achievement of pre0traumatic facial symmetry/orientation.; This parameter shall be recorded on a 4-point Likert scale (not satisfied, somewhat dissatisfied, somewhat satisfied, satisfied).