Status:
RECRUITING
Treatment of Intra-articular Fractures of the Mandibular Condyle
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Intra-articular Fracture of the Mandibular Condyle
Eligibility:
All Genders
18-84 years
Phase:
NA
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). H...
Detailed Description
The mandibular condyle is one of the most frequent locations of facial fractures. It can lead to severe functional impairment if the occlusion is not properly restored and the mandibular mobility not ...
Eligibility Criteria
Inclusion
- 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 (a ramus shortening ≥2 mm on CT-scan is necessary in case of other associated mandibular or occluso-facial fractures)
- 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
- 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
Key Trial Info
Start Date :
May 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04776473
Start Date
May 3 2023
End Date
May 1 2027
Last Update
May 16 2023
Active Locations (7)
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1
CHU Angers
Angers, France
2
Hôpital Annecy Genevois
Annecy, France, 74370
3
APHM - Hôpital de la Conception
Marseille, France, 13005
4
CHU de Nantes
Nantes, France, 44093