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

Primary Purpose

Intra-articular Fracture of the Mandibular Condyle

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Open treatment
Closed treatment
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intra-articular Fracture of the Mandibular Condyle focused on measuring intra-articular fracture, mandibular condyle, surgical treatment, conservative treatment

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Angers
  • Hôpital Annecy Genevois
  • APHM - Hôpital de la Conception
  • CHU de Nantes
  • Hôpital Pitié-SalpêtrièreRecruiting
  • Hôpitaux Universitaires de Strasbourg
  • CHU Purpan - Hôpital Pierre-Paul Riquet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Open (i.e. surgical) treatment

Closed (i.e. conservative) treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximal mouth opening (in mm)
Measured following the method described for primary outcome.
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
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
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
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
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)
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.
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).
Duration of sick leave
Time to normal activity recovery
Patient will asked on return to work and to normal daily activities (social activities, eating, sports)
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.
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
Compliance with the intervention - Duration of permanent MMF
The patient will fill in a notebook the number of permanent MMF since last patient report
Compliance with the intervention - Duration of transient MMF
The duration of permanent MMF the duration of transient MMF since last patient report
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.
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

Full Information

First Posted
February 17, 2021
Last Updated
May 15, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04776473
Brief Title
Treatment of Intra-articular Fractures of the Mandibular Condyle
Acronym
FIAC
Official Title
Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-articular Fracture of the Mandibular Condyle
Keywords
intra-articular fracture, mandibular condyle, surgical treatment, conservative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open (i.e. surgical) treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Closed (i.e. conservative) treatment
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Open treatment
Other Intervention Name(s)
Surgical treatment
Intervention Description
Open (i.e. surgical) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.
Intervention Type
Other
Intervention Name(s)
Closed treatment
Other Intervention Name(s)
Conservative treatment
Intervention Description
Closed (i.e. conservative) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.
Primary Outcome Measure Information:
Title
Maximal mouth opening (in mm) at 3 months
Description
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
Time Frame
3 months (+/-10 days)
Secondary Outcome Measure Information:
Title
Maximal mouth opening (in mm)
Description
Measured following the method described for primary outcome.
Time Frame
3 weeks (+/- 7 days), 6 weeks (+/-7 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Title
Maximal mandibular protrusion (in mm)
Description
- 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
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
Title
Maximal lateral excursion (in mm)
Description
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
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
Title
Lateral deviation of the mandible during mouth opening
Description
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
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
Title
Occlusal disturbance reported by the patient
Description
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
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
Title
Occlusal disturbance evaluated by the surgeon
Description
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)
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
Title
Evaluation of pain using a visual analog scale
Description
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.
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
Title
Subjective functional impairment evaluated by the patient using the Mandibular Function Impairment Questionnaire (MFIQ)
Description
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).
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
Title
Duration of sick leave
Time Frame
From treatment until 12 months
Title
Time to normal activity recovery
Description
Patient will asked on return to work and to normal daily activities (social activities, eating, sports)
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
Title
Compliance with the intervention - Number of appointments with a physical therapist
Description
The patient will fill in a notebook the number of appointments with a physical therapist since last patient report.
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
Title
Compliance with the intervention - Number of self-training sessions
Description
The patient will fill in a notebook the number of the number of self-training sessions since last patient report
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
Title
Compliance with the intervention - Duration of permanent MMF
Description
The patient will fill in a notebook the number of permanent MMF since last patient report
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
Title
Compliance with the intervention - Duration of transient MMF
Description
The duration of permanent MMF the duration of transient MMF since last patient report
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
Title
Compliance with the intervention - Duration of application of mobilization elastic band
Description
The patient will fill in a notebook the 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
Title
Compliance with the intervention - Average and Maximal pain
Description
The patient will fill in a notebook the average and maximal pain rate since last patient report
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (≥18 y-o) < 85 years 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 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) Unilateral or bilateral fracture Isolated or associated with other facial / extra-facial skeleton / dental / soft tissue lesions Treatment within 14 days post trauma Affiliation to a social security regime (excepted AME) Written informed consent Exclusion Criteria: Contraindication to surgical treatment (for any medical or anatomical reason, like comminuted fracture for instance) Major teeth loss or edentulous patient (occlusion impossible to assess) History of mandibular fracture History of temporo-mandibular joint (TMJ) disorder Dentofacial dysmorphosis causing significant malocclusion Predictable inability to comply with the follow-up Unconsciousness / severe polytrauma Participation in another interventional study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas SCHOUMAN, MD
Phone
(0)1 42 16 13 01
Ext
+33
Email
thomas.schouman@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mourad BENASSAROU, MD
Phone
(0)1 42 16 13 01
Ext
+33
Email
mourad-azzedine.benassarou@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas SCHOUMAN, MD
Organizational Affiliation
AP-HP - Hôpital Pitié-Salpêtrière
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Annecy Genevois
City
Annecy
ZIP/Postal Code
74370
Country
France
Individual Site Status
Not yet recruiting
Facility Name
APHM - Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas SCHOUMAN, MD, PhD
Phone
(0)1 42 16 13 01
Ext
+33
Email
thomas.schouman@aphp.fr
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU Purpan - Hôpital Pierre-Paul Riquet
City
Toulouse
ZIP/Postal Code
31300
Country
France
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Treatment of Intra-articular Fractures of the Mandibular Condyle

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