Treatment of Intra-articular Fractures of the Mandibular Condyle

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.

• Maximal mouth opening (in mm) [Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment]
• Maximal mandibular protrusion (in mm) [Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment]
• Maximal lateral excursion (in mm) [Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment]
• Lateral deviation of the mandible during mouth opening [Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment]
• Occlusal disturbance reported by the patient [Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment]
• Occlusal disturbance evaluated by the surgeon [Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment]
• Evaluation of pain using a visual analog scale [Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment]
• Subjective functional impairment evaluated by the patient using the Mandibular Function Impairment Questionnaire (MFIQ) [Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment]
• Duration of sick leave [Time frame: From treatment until 12 months]
• Time to normal activity recovery [Time frame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12]
• Compliance with the intervention - Number of appointments with a physical therapist [Time frame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12]
• Compliance with the intervention - Number of self-training sessions [Time frame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12]