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

Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Intra-articular Fracture of the Mandibular Condyle
• Intervention / Treatment: Procedure: Open treatment; Other: Closed treatment

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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas SCHOUMAN, MD; Phone Number: +33 (0)1 42 16 13 01; Email: thomas.schouman@aphp.fr
• Study Contact Backup: Name: Mourad BENASSAROU, MD; Phone Number: +33 (0)1 42 16 13 01; Email: mourad-azzedine.benassarou@aphp.fr

Study Locations

• France
  • Angers, France
    • Not yet recruiting
    • Chu Angers
  • Annecy, France, 74370
    • Not yet recruiting
    • Hôpital Annecy Genevois
  • Marseille, France, 13005
    • Not yet recruiting
    • APHM - Hôpital de la Conception
  • Nantes, France, 44093
    • Not yet recruiting
    • CHU de Nantes
  • Paris, France, 75013
    • Recruiting
    • Hôpital Pitié-Salpêtrière
    • Contact: Thomas SCHOUMAN, MD, PhD; Phone Number: +33 (0)1 42 16 13 01; Email: thomas.schouman@aphp.fr
  • Strasbourg, France, 67200
    • Not yet recruiting
    • Hopitaux Universitaires de Strasbourg
  • Toulouse, France, 31300
    • Not yet recruiting
    • CHU Purpan - Hôpital Pierre-Paul Riquet

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Surgical treatment
Other: 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 Names: Conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal mouth opening (in mm) at 3 months	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	3 months (+/-10 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal mouth opening (in mm)	Measured following the method described for primary outcome.	3 weeks (+/- 7 days), 6 weeks (+/-7 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Maximal mandibular protrusion (in mm)	- 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 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)	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	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	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	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	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	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	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)	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	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.	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)	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).	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		From treatment until 12 months
Time to normal activity recovery	Patient will asked on return to work and to normal daily activities (social activities, eating, sports)	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	The patient will fill in a notebook the number of appointments with a physical therapist since last patient report.	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	The patient will fill in a notebook the number of the number of self-training sessions since last patient report	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 - Duration of permanent MMF	The patient will fill in a notebook the number of permanent MMF since last patient report	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 - Duration of transient MMF	The duration of permanent MMF the duration of transient MMF since last patient report	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 - Duration of application of mobilization elastic band	The patient will fill in a notebook the duration of application of mobilization elastic band.	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 - Average and Maximal pain	The patient will fill in a notebook the average and maximal pain rate since last patient report	Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Thomas SCHOUMAN, MD, AP-HP - Hôpital Pitié-Salpétrière

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Anticipated): August 1, 2026
• Study Completion (Anticipated): May 1, 2027

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: surgical treatment; conservative treatment; mandibular condyle; intra-articular fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Intra-Articular Fractures
• Other Study ID Numbers: APHP180606; 2019-A00252-55 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No