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出境医 / 临床实验 / Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

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.

Condition or disease Intervention/treatment Phase
Mandibular Fractures Procedure: Open Reduction & Internal Fixation Procedure: Closed Reduction & External Fixation Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Open Reduction With Internal Fixation and Closed Reduction With External Fixation of Mandibular Sub-Condylar Fractures
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : November 15, 2015
Actual Study Completion Date : November 15, 2015
Arms and Interventions
Arm Intervention/treatment
Experimental: ORIF
Open Reduction & Internal Fixation
 Procedure: Open Reduction & Internal Fixation
Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws
Active Comparator: CREF
Closed Reduction & External Fixation
 Procedure: Closed Reduction & External Fixation
Patients underwent closed reduction of the fracture and external fixation by arch bars & guided elastics
Outcome Measures
Primary Outcome Measures :
  1. Mouth Opening [ Time Frame: 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"

  2. Occlusion [ Time Frame: 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 :
  1. Complications [ Time Frame: 6 months ]
    The frequency of complications with either mode of treatment shall be recorded

  2. Cost-Effectiveness [ Time Frame: 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.


  3. Patient Satisfaction [ Time Frame: 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 Criteria
Layout table for eligibility information
Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE March 24, 2018
First Posted Date  ICMJE April 11, 2018
Last Update Posted Date April 11, 2018
Actual Study Start Date  ICMJE November 1, 2014
Actual Primary Completion Date November 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • Mouth Opening [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • Complications [ Time Frame: 6 months ]
    The frequency of complications with either mode of treatment shall be recorded
  • Cost-Effectiveness [ Time Frame: 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 [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures
Official Title  ICMJE Comparison of Open Reduction With Internal Fixation and Closed Reduction With External Fixation of Mandibular Sub-Condylar Fractures
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mandibular Fractures
Intervention  ICMJE
  • Procedure: Open Reduction & Internal Fixation
    Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws
  • Procedure: Closed Reduction & External Fixation
    Patients underwent closed reduction of the fracture and external fixation by arch bars & guided elastics
Study Arms  ICMJE
  • Experimental: ORIF
    Open Reduction & Internal Fixation
    Intervention: Procedure: Open Reduction & Internal Fixation
  • Active Comparator: CREF
    Closed Reduction & External Fixation
    Intervention: Procedure: Closed Reduction & External Fixation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2018) 		70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 15, 2015
Actual Primary Completion Date November 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03494309
Other Study ID Numbers  ICMJE 107/RC/KEMU
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samira S Baloch, King Edward Medical University
Study Sponsor  ICMJE King Edward Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account King Edward Medical University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP