Clinical trial NCT04776473: Treatment of Intra-articular Fractures of the Mandibular Condyle
Official title: Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intra-articular Fracture of the Mandibular Condyle
Keywords: intra-articular fracture
mandibular condyle
surgical treatment
conservative treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

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 dysmorphosis causing significant malocclusion
6. Predictable inability to comply with the follow-up
7. Unconsciousness / severe polytrauma
8. Participation in another interventional study

Primary outcomes:
measure: Maximal mouth opening (in mm) at 3 months
timeFrame: 3 months (+/-10 days)
Secondary outcomes:
measure: Maximal mouth opening (in mm)
timeFrame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
measure: Maximal mandibular protrusion (in mm)
timeFrame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
measure: Maximal lateral excursion (in mm)
timeFrame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
measure: Lateral deviation of the mandible during mouth opening
timeFrame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
measure: Occlusal disturbance reported by the patient
timeFrame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
measure: Occlusal disturbance evaluated by the surgeon
timeFrame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
measure: Evaluation of pain using a visual analog scale
timeFrame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
measure: Subjective functional impairment evaluated by the patient using the Mandibular Function Impairment Questionnaire (MFIQ)
timeFrame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
measure: Duration of sick leave
timeFrame: From treatment until 12 months
measure: Time to normal activity recovery
timeFrame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
measure: Compliance with the intervention - Number of appointments with a physical therapist
timeFrame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
measure: Compliance with the intervention - Number of self-training sessions
timeFrame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
measure: Compliance with the intervention - Duration of permanent MMF
timeFrame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
measure: Compliance with the intervention - Duration of transient MMF
timeFrame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
measure: Compliance with the intervention - Duration of application of mobilization elastic band
timeFrame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
measure: Compliance with the intervention - Average and Maximal pain
timeFrame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Annecy
country: France
facility: Hôpital Annecy Genevois
city: Marseille
country: France
facility: APHM - Hôpital de la Conception
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: CHU Purpan - Hôpital Pierre-Paul Riquet
Study officials:
affiliation: AP-HP - Hôpital Pitié-Salpêtrière
name: Thomas SCHOUMAN, MD
role: PRINCIPAL_INVESTIGATOR
References: