Treatment of Intra-articular Fractures of the Mandibular Condyle

Last updated: May 15, 2023
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Closed treatment

Open treatment

Clinical Study ID

NCT04776473
APHP180606
2019-A00252-55
  • Ages 18-84
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult (≥18 y-o) < 85 years
  2. Displaced non-comminuted intra-articular fracture of the mandibular condyle (IAFC) asdefined 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 ramusshortening ≥2 mm on CT-scan is necessary in case of other associated mandibular oroccluso-facial fractures)
  4. Unilateral or bilateral fracture
  5. Isolated or associated with other facial / extra-facial skeleton / dental / softtissue lesions
  6. Treatment within 14 days post trauma
  7. Affiliation to a social security regime (excepted AME)
  8. Written informed consent

Exclusion

Exclusion Criteria:

  1. Contraindication to surgical treatment (for any medical or anatomical reason, likecomminuted 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

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Closed treatment
Phase:
Study Start date:
May 03, 2023
Estimated Completion Date:
May 31, 2027

Study 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.

Connect with a study center

  • CHU Angers

    Angers,
    France

    Site Not Available

  • Hôpital Annecy Genevois

    Annecy, 74370
    France

    Site Not Available

  • CHU Dijon Bourgogne

    Dijon, 21079 Cedex
    France

    Site Not Available

  • APHM - Hôpital de la Conception

    Marseille, 13005
    France

    Site Not Available

  • CHU de Nantes

    Nantes, 44093
    France

    Site Not Available

  • Hôpital Pitié-Salpêtrière

    Paris, 75013
    France

    Active - Recruiting

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67200
    France

    Site Not Available

  • CHU Purpan - Hôpital Pierre-Paul Riquet

    Toulouse, 31300
    France

    Site Not Available

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