Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Open Reduction With Internal Fixation and Closed Reduction With External Fixation of Mandibular Sub-Condylar Fractures

Conditions
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Mandibular Fractures

Intervention / Treatment
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* Procedure: Open Reduction & Internal Fixation
* Procedure: Closed Reduction & External Fixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ORIF<br>Open Reduction & Internal Fixation | Procedure: Open Reduction & Internal Fixation<br>* Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws<br>|
| Active Comparator: CREF<br>Closed Reduction & External Fixation | Procedure: Closed Reduction & External Fixation<br>* Patients underwent closed reduction of the fracture and external fixation by arch bars & guided elastics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mouth Opening | 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 | 6 months | 
| Occlusion | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | The frequency of complications with either mode of treatment shall be recorded | 6 months | 
| Cost-Effectiveness | 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. | 6 months | 
| Patient Satisfaction | 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). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mandibular Subcondylar Fractures, Mouth Opening, Open Reduction and Internal Fixation, Closed Reduction with External Fixation