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Treatment of Intra-articular Fractures of the Mandibular Condyle

RecruitingNAAges 18 Years - 84 YearsAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

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 randomize

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adult (≥18 y-o) \< 85 years 2. 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 3. Objectifiable induced malocclusion and/or ramus shortening ≥2 mm on CT-scan (a ramus shortening ≥2 mm on CT-scan is necessary in case of other associated mandibular or occluso-facial fractures) 4. Unilateral or bilateral fracture 5. Isolated or associated with other facial / extra-facial skeleton / dental / soft tissue lesions 6. Treatment within 14 days post trauma 7. Affiliation to a social security regime (excepted AME) 8. Written informed consent Exclusion Criteria: 1. Contraindication to surgical treatment (for any medical or anatomical reason, like comminuted fracture for instance) 2. Major teeth loss or edentulous patient (occlusion impossible to assess) 3. History of mandibular fracture 4. History of temporo-mandibular joint (TMJ) disorder 5. Dentofacial dysmorphosis causing significant malocclusion 6. Predictable inability to comply with the follow-up 7. Unconsciousness / severe polytrauma 8. Participation in another interventional study
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What it tests

  • Open treatment
  • Closed treatment
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Where

7 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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