Treatment of Intra-articular Fractures of the Mandibular Condyle (FIAC)
Intra-articular Fracture of the Mandibular Condyle
About this trial
This is an interventional treatment trial for Intra-articular Fracture of the Mandibular Condyle focused on measuring intra-articular fracture, mandibular condyle, surgical treatment, conservative treatment
Eligibility Criteria
Inclusion Criteria:
- Adult (≥18 y-o) < 85 years
- Displaced non-comminuted intra-articular fracture of the mandibular condyle (IAFC) as defined by a fracture line above a horizontal line tangent to the mandibular notch
- Objectifiable induced malocclusion and/or ramus shortening ≥2 mm on CT-scan (required when more than 1 mandibular fracture)
- Unilateral or bilateral fracture
- Isolated or associated with other facial / extra-facial skeleton / dental / soft tissue lesions
- Treatment within 14 days post trauma
- Affiliation to a social security regime (excepted AME)
- Written informed consent
Exclusion Criteria:
- Contraindication to surgical treatment (for any medical or anatomical reason, like comminuted fracture for instance)
- Major teeth loss or edentulous patient (occlusion impossible to assess)
- History of mandibular fracture
- History of temporo-mandibular joint (TMJ) disorder
- Dentofacial dysmorphosis causing significant malocclusion
- Predictable inability to comply with the follow-up
- Unconsciousness / severe polytrauma
- Participation in another interventional study
Sites / Locations
- CHU Angers
- Hôpital Annecy Genevois
- APHM - Hôpital de la Conception
- CHU de Nantes
- Hôpital Pitié-SalpêtrièreRecruiting
- Hôpitaux Universitaires de Strasbourg
- CHU Purpan - Hôpital Pierre-Paul Riquet
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Open (i.e. surgical) treatment
Closed (i.e. conservative) treatment
This includes reduction and internal fixation of the fracture (ORIF) performed using the preferred surgical approach and bone implants of the including centre that could be associated with one or several items among the following: physical therapy based on exercises done by the patient himself physical therapy performed by a specialized/non-specialized physical therapist arch bars / screws / splint use for transient MMF arch bars / screws / splint use for passive mobilization of the mandible
To date, there is no consensus on which procedures should be used in case of conservative treatment, which may vary between centres and, for a same centre, between patients. This includes one or several items among the following: physical therapy based on exercises done by the patient himself physical therapy performed by a specialized/non-specialized physical therapist arch bars / screws / splint use for transient maxillo-mandibular fixation (MMF) (15 days max) arch bars / screws / splint use for passive mobilization of the mandible