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Treatment of Intra-articular Fractures of the Mandibular Condyle
Sponsor: Assistance Publique - Hôpitaux de Paris
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
Open treatment
Open (i.e. surgical) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.
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