NCT04776473 Treatment of Intra-articular Fractures of the Mandibular Condyle
| NCT ID | NCT04776473 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Intra-articular Fracture of the Mandibular Condyle |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-05-03 |
| Primary Completion | 2026-08 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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 d