Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

NCT03494309 — Not applicable, Completed, 70 participants, King Edward Medical University

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

Registry	NCT03494309
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	70 (Actual)
Sponsor	King Edward Medical University (Other)
Conditions	Mandibular Fractures
Interventions	Open Reduction & Internal Fixation, Closed Reduction & External Fixation (Procedure)
Dates	start 2014-11-01, primary completion 2015-11-15, completion 2015-11-15, first posted 2018-04-11, last updated 2018-04-11

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
ORIF	Experimental	Procedure: Open Reduction & Internal Fixation	Open Reduction \& Internal Fixation
CREF	Active comparator	Procedure: Closed Reduction & External Fixation	Closed Reduction \& External Fixation

Open Reduction & Internal Fixation (Procedure): Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws
Closed Reduction & External Fixation (Procedure): Patients underwent closed reduction of the fracture and external fixation by arch bars \& guided elastics

+Outcome measures

Primary outcomes

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 outcomes

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).

+Eligibility

Sex: All, ages: 16 Years to 60 Years

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

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