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RECRUITING
NCT04776473
NA

Treatment of Intra-articular Fractures of the Mandibular Condyle

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

Intra-articular fractures of the mandibular condyle ((IAFC) are usually treated by means of physical therapy with or without transient maxillo-mandibular fixation (conservative or closed treatment). However, this can lead to incomplete manducatory function recovery due to limited mandibular mobility. During the last 15 years, a growing interest has emerged for open (surgical) treatment of these fractures. Although there is more and more evidence suggesting that the open treatment may be the treatment of choice for selected cases of subcondylar fractures, the best option remains controversial for high condylar fractures. The primary objective of the trial is to compare mandibular mobility at 3 months post-treatment between open (surgical) and closed (conservative) treatment of intra-articular fracture (high fracture) of the mandibular condyle. This study is an open multicenter randomized controlled trial with 2 parallel arms. Eligible patients will be randomized 1 :1 between open and closed-treatment group.

Official title: Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2023-05-03

Completion Date

2027-05

Last Updated

2023-05-16

Healthy Volunteers

No

Interventions

PROCEDURE

Open treatment

Open (i.e. surgical) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.

OTHER

Closed treatment

Closed (i.e. conservative) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.

Locations (7)

CHU Angers

Angers, France

Hôpital Annecy Genevois

Annecy, France

APHM - Hôpital de la Conception

Marseille, France

CHU de Nantes

Nantes, France

Hôpital Pitié-Salpêtrière

Paris, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

CHU Purpan - Hôpital Pierre-Paul Riquet

Toulouse, France