Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT04776473 En recrutement IDF

Titre

Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial

Type

Interventional

Pathologie

Fractures osseuses
Fractures articulaires

Phase

N/A

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

mai 2023

Date de fin

mai 2027

Dernière mise à jour

17 septembre 2025

Résumé

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.

Détail

Voir le détail 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 recovered totally or within an acceptable range. Most frequent sequels of these fractures include limitation of mandibular movements resulting in limited mouth opening, occlusal disturbance causing chewing malfunction, chronic pain, chronic temporo-mandibular joint (TMJ) disorder and facial asymmetry. The risk of permanent limited mouth opening is even higher when the fracture is located inside the TMJ. Although the superiority of surgical treatment is now widely accepted for low-level fractures of the condylar unit (i.e., extra-articular fractures) the treatment of fractures involving the TMJ in adult patients is still controversial. Treatment principles in these fractures can be ranked in two groups: closed and open treatments. Closed treatment - also called closed reduction or conservative treatment - consists in prolonged physical therapy frequently associated with transient maxillo-mandibular fixation (MMF). Open treatment consists in open reduction and internal fixation of the fracture (ORIF). No randomized controlled trial has ever evaluated the superiority of open versus closed treatment, and treatment strategy for IAFC remains a matter of ongoing debate. The primary objective of this 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. The secondary objectives are to compare between open (surgical) and closed (conservative) treatments: At 3 weeks, 6 weeks, 3 months, 6 months, and 12 months post-treatment: - maximal mouth opening (in mm) - maximal mandibular protrusion (in mm), - maximal lateral excursion (in mm), - lateral deviation of the mandible during mouth opening - occlusal disturbance evaluated by both the patient and the surgeon - pain using a visual analog scale - subjective functional impairment as assessed by the Mandibular Function Impairment Questionnaire Overall: - duration of sick leave - time to normal activity recovery (social activities, eating, sports) We will also evaluate compliance with the intervention. This trial is an open multicenter randomized controlled trial with 2 parallel arms. Eligible patients will be randomized 1 :1 between open and closed-treatment group. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP Assistance publique - Hôpitaux de Paris		En recrutement IDF	13/12/2025 07:21:43	Contacter
	AP-HP - Hôpital La Pitié-Salpêtrière
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
APHM - Hôpital de la Conception - 13005 - Marseille - France		Recrutement non commencé		Contact (sur clinicalTrials)
CHU Angers - Angers - France		Recrutement non commencé		Contact (sur clinicalTrials)
CHU de Nantes - 44093 - Nantes - France		Recrutement non commencé		Contact (sur clinicalTrials)
CHU Purpan - Hôpital Pierre-Paul Riquet - 31300 - Toulouse - France		Recrutement non commencé		Contact (sur clinicalTrials)
Hôpital Annecy Genevois - 74370 - Annecy - France		Recrutement non commencé		Contact (sur clinicalTrials)
Hôpital Pitié-Salpêtrière - 75013 - Paris - France	Thomas SCHOUMAN, MD, PhD	En recrutement		Contact (sur clinicalTrials)
Hôpitaux Universitaires de Strasbourg - 67200 - Strasbourg - France		Recrutement non commencé		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

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

NCT04776473 - Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial

Informations générales
Etablissements
Critères
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