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

• ClinicalTrials.gov Identifier: NCT04776473
• Recruitment Status: Not yet recruiting
• First Posted: March 1, 2021
• Last Update Posted: December 14, 2021
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intra-articular Fracture of the Mandibular Condyle	Procedure: Open treatment; Other: Closed treatment	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial
• Estimated Study Start Date: February 2022
• Estimated Primary Completion Date: May 2025
• Estimated Study Completion Date: February 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Open (i.e. surgical) treatment; 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	Procedure: Open treatment; Open (i.e. surgical) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.; Other Name: Surgical treatment
Closed (i.e. conservative) treatment; 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	Other: Closed treatment; Closed (i.e. conservative) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.; Other Name: Conservative treatment

Outcome Measures

Primary Outcome Measures :

1. Maximal mouth opening (in mm) at 3 months [ Time Frame: 3 months (+/-10 days) ]
   It will be obtained by measuring the interincisal distance at maximum mouth opening with a caliper or a ruler. The patient will be first asked to open the mouth as widely as possible for 3 seconds and to rest for 5 seconds. This sequence will be repeated 2 times and at the third repetition the patient will keep his/her mouth opened while the physician will measure inter-incisal distance

Secondary Outcome Measures :

1. 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 ]
   Measured following the method described for primary outcome.
2. 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 mandibular protrusion in mm measured with a caliper or with a ruler, asking the patient to move the mandible as far as possible in the forward direction while keeping a slight contact between the dental arches. This measure will be done only after repetition of mouth opening and measurement of the maximum mouth opening, which will warm up mandibular mobilization
3. 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 ]
   Maximal lateral excursion in mm measured with a caliper or with a ruler, asking the patient to move the mandible as far as possible in the right and left directions while keeping a slight contact between the dental arches. These measurements will be done only after repetition of mouth opening and measurement of the maximum mouth opening, which will warm up mandibular mobilization
4. 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 ]
   Lateral deviation of the mandible during mouth opening will be ranked as straight, right, or left. This observation can be made during the first measurement of mandibular opening
5. 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 ]

   The patient will be asked to describe how his/her teeth touch as referring to his/her previous occlusion. He/she will rank his/her occlusion as:

   • not modified
   • slightly modified as compared to before the trauma but with no significant disturbance
   • significantly disturbed
6. 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 ]

   The surgeon will ask the patient to bite and describe the occlusion as:

   • Not modified
   • Open bite: barely detectable (right / anterior / left) or clearly detectable (right / anterior / left)
   • Premature contact: barely detectable (right / anterior / left) or clearly detectable (right / anterior / left)
7. 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 ]

   The patient will be asked to rate his/her maximum pain in the last 2 days on a visual analog scale, 0 representing no pain and 10 representing the worst pain imaginable.

   For bilateral fractures, the pain will be assessed separately on each side.

8. 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 ]
   The Mandibular Function Impairment Questionnaire (MFIQ) consisting in 17 items, rated between 0 and 4, which describes the difficulty in several common movement/activities involving the mandible (see questionnaire 1).
9. Duration of sick leave [ Time Frame: From treatment until 12 months ]
10. 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 ]
    Patient will asked on return to work and to normal daily activities (social activities, eating, sports)
11. 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 ]
    The patient will fill in a notebook the number of appointments with a physical therapist since last patient report.
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 ]
    The patient will fill in a notebook the number of the number of self-training sessions since last patient report
13. Compliance with the intervention - Duration of permanent MMF [ 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 ]
    The patient will fill in a notebook the number of permanent MMF since last patient report
14. Compliance with the intervention - Duration of transient MMF [ 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 ]
    The duration of permanent MMF the duration of transient MMF since last patient report
15. Compliance with the intervention - Duration of application of mobilization elastic band [ 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 ]
    The patient will fill in a notebook the duration of application of mobilization elastic band.
16. Compliance with the intervention - Average and Maximal pain [ 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 ]
    The patient will fill in a notebook the average and maximal pain rate since last patient report

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 84 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 (required when more than 1 mandibular fracture)
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

Contacts and Locations

Contacts

Contact: Thomas SCHOUMAN, MD; (0)1 42 16 13 01 ext +33; thomas.schouman@aphp.fr

Contact: Mourad BENASSAROU, MD; (0)1 42 16 13 01 ext +33; mourad-azzedine.benassarou@aphp.fr

Locations

France

Hôpital Annecy Genevois

Annecy, France, 74370

CHU Dijon Bourgogne

Dijon, France, 21079 Cedex

APHM - Hôpital de la Conception

Marseille, France, 13005

CHU de Nantes

Nantes, France, 44093

Hôpital Pitié-Salpêtrière

Paris, France, 75013

Contact: Thomas SCHOUMAN, MD, PhD (0)1 42 16 13 01 ext +33 thomas.schouman@aphp.fr

Hôpitaux Universitaires de Strasbourg

Strasbourg, France, 67200

CHU Purpan - Hôpital Pierre-Paul Riquet

Toulouse, France, 31300

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Thomas SCHOUMAN, MD; AP-HP - Hôpital Pitié-Salpêtrière

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04776473
• Other Study ID Numbers: APHP180606; 2019-A00252-55 ( Other Identifier: IDRCB )
• First Posted: March 1, 2021
• Last Update Posted: December 14, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF)
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

intra-articular fracture; mandibular condyle; surgical treatment; conservative treatment

Additional relevant MeSH terms:

Fractures, Bone; Intra-Articular Fractures; Wounds and Injuries