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Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

Primary Purpose

Mandibular Fractures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open Reduction & Internal Fixation
Closed Reduction & External Fixation
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Fractures focused on measuring Mandibular Subcondylar Fractures, Mouth Opening, Open Reduction and Internal Fixation, Closed Reduction with External Fixation

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ORIF

    CREF

    Arm Description

    Open Reduction & Internal Fixation

    Closed Reduction & External Fixation

    Outcomes

    Primary Outcome Measures

    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"
    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.

    Secondary Outcome Measures

    Complications
    The frequency of complications with either mode of treatment shall be recorded
    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.
    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).

    Full Information

    First Posted
    March 24, 2018
    Last Updated
    April 10, 2018
    Sponsor
    King Edward Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03494309
    Brief Title
    Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures
    Official Title
    Comparison of Open Reduction With Internal Fixation and Closed Reduction With External Fixation of Mandibular Sub-Condylar Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2014 (Actual)
    Primary Completion Date
    November 15, 2015 (Actual)
    Study Completion Date
    November 15, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Edward Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mandibular Fractures
    Keywords
    Mandibular Subcondylar Fractures, Mouth Opening, Open Reduction and Internal Fixation, Closed Reduction with External Fixation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ORIF
    Arm Type
    Experimental
    Arm Description
    Open Reduction & Internal Fixation
    Arm Title
    CREF
    Arm Type
    Active Comparator
    Arm Description
    Closed Reduction & External Fixation
    Intervention Type
    Procedure
    Intervention Name(s)
    Open Reduction & Internal Fixation
    Intervention Description
    Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws
    Intervention Type
    Procedure
    Intervention Name(s)
    Closed Reduction & External Fixation
    Intervention Description
    Patients underwent closed reduction of the fracture and external fixation by arch bars & guided elastics
    Primary Outcome Measure Information:
    Title
    Mouth Opening
    Description
    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"
    Time Frame
    6 months
    Title
    Occlusion
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Complications
    Description
    The frequency of complications with either mode of treatment shall be recorded
    Time Frame
    6 months
    Title
    Cost-Effectiveness
    Description
    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.
    Time Frame
    6 months
    Title
    Patient Satisfaction
    Description
    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).
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

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