Actively Recruiting
Treatment of Intra-articular Fractures of the Mandibular Condyle
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-05-16
110
Participants Needed
7
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Intra-articular Fractures of the Mandibular Condyle
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to under 85 years
- Displaced non-comminuted intra-articular fracture of the mandibular condyle above the mandibular notch
- Malocclusion and/or ramus shortening of 2 mm or more on CT scan (required if other facial fractures present)
- Unilateral or bilateral fracture
- Isolated or with other facial, skeletal, dental, or soft tissue injuries
- Treatment planned within 14 days after trauma
- Affiliated to a social security system (except AME)
- Provided written informed consent
You will not qualify if you...
- Contraindication to surgical treatment for any medical or anatomical reason
- Major teeth loss or edentulous preventing occlusion assessment
- History of mandibular fracture
- History of temporo-mandibular joint disorder
- Dentofacial dysmorphosis causing significant malocclusion
- Expected inability to comply with follow-up
- Unconsciousness or severe polytrauma
- Participation in another interventional study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
CHU Angers
Angers, France
Not Yet Recruiting
2
Hôpital Annecy Genevois
Annecy, France, 74370
Not Yet Recruiting
3
APHM - Hôpital de la Conception
Marseille, France, 13005
Not Yet Recruiting
4
CHU de Nantes
Nantes, France, 44093
Not Yet Recruiting
5
Hôpital Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
6
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67200
Not Yet Recruiting
7
CHU Purpan - Hôpital Pierre-Paul Riquet
Toulouse, France, 31300
Not Yet Recruiting
Research Team
T
Thomas SCHOUMAN, MD
CONTACT
M
Mourad BENASSAROU, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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