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OpenTrials
Completed

NCT Number: NCT03494309

Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

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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Key information

Conditions

Mandibular Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 11, 2018
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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