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Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

K

King Edward Medical University

Status

Completed

Conditions

Mandibular Fractures

Treatments

Procedure: Closed Reduction & External Fixation
Procedure: Open Reduction & Internal Fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT03494309
107/RC/KEMU

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

16 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

ORIF
Experimental group
Description:
Open Reduction \& Internal Fixation
Treatment:
Procedure: Open Reduction & Internal Fixation
CREF
Active Comparator group
Description:
Closed Reduction \& External Fixation
Treatment:
Procedure: Closed Reduction & External Fixation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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