Treatment of Intra-articular Fractures of the Mandibular Condyle (FIAC)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Intra-articular Fracture of the Mandibular Condyle

Treatments: Procedure: Open treatment; Other: Closed treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04776473

2019-A00252-55 (Other Identifier)

APHP180606

Details and patient eligibility

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.

Full 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 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Open (i.e. surgical) treatment

Experimental group

Description:

This includes reduction and internal fixation of the fracture (ORIF) performed using the preferred surgical approach and bone implants of the including centre that could be associated with one or several items among the following: * physical therapy based on exercises done by the patient himself * physical therapy performed by a specialized/non-specialized physical therapist * arch bars / screws / splint use for transient MMF * arch bars / screws / splint use for passive mobilization of the mandible

Treatment:

Procedure: Open treatment

Closed (i.e. conservative) treatment

Other group

Description:

To date, there is no consensus on which procedures should be used in case of conservative treatment, which may vary between centres and, for a same centre, between patients. This includes one or several items among the following: * physical therapy based on exercises done by the patient himself * physical therapy performed by a specialized/non-specialized physical therapist * arch bars / screws / splint use for transient maxillo-mandibular fixation (MMF) (15 days max) * arch bars / screws / splint use for passive mobilization of the mandible

Treatment:

Other: Closed treatment