Intra-articular Fracture of the Mandibular Condyle Clinical Trial
— FIACOfficial title:
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.
| Status | Recruiting |
| Enrollment | 110 |
| Est. completion date | May 2027 |
| Est. primary completion date | August 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 84 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Angers | Angers | |
| France | Hôpital Annecy Genevois | Annecy | |
| France | APHM - Hôpital de la Conception | Marseille | |
| France | CHU de Nantes | Nantes | |
| France | Hôpital Pitié-Salpêtrière | Paris | |
| France | Hôpitaux Universitaires de Strasbourg | Strasbourg | |
| France | CHU Purpan - Hôpital Pierre-Paul Riquet | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Duration of sick leave | From treatment until 12 months | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |