Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

Mandibular Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494309
• Other study ID #: 107/RC/KEMU
• Status: Completed
• Phase: N/A
• First received: March 24, 2018
• Last updated: April 10, 2018
• Start date: November 1, 2014
• Est. completion date: November 15, 2015

Study information

• Verified date: April 2018
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 15, 2015
• Est. primary completion date: November 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

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
• Closed Reduction & External Fixation
Patients underwent closed reduction of the fracture and external fixation by arch bars & guided elastics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Complications	The frequency of complications with either mode of treatment shall be recorded	6 months
Secondary	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
Secondary	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