Treatment of Intra-articular Fractures of the Mandibular Condyle

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2027-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bilateral Condylar Fractures Registry

NCT02884765

Bilateral Condylar Fracture of the Mandible

COMPLETED

Mandibular Angle Fracture and Interframents Gap

NCT04729036

Mandibular Fractures

UNKNOWN

Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture

NCT06333197

Mandibular Fractures

NOT_YET_RECRUITING NA

Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture

NCT03747666

Mandible Fracture

UNKNOWN NA

A New Surgical Approach to Treat Medial or Low Condylar Fractures

NCT01851031

Fracture of Condylar Process

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intra-articular Fracture of the Mandibular Condyle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Open treatment

Intervention Type PROCEDURE

Open (i.e. surgical) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.

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

Group Type OTHER

Closed treatment

Intervention Type OTHER

Closed (i.e. conservative) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Open treatment

Open (i.e. surgical) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.

Intervention Type PROCEDURE

Closed treatment

Closed (i.e. conservative) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Surgical treatment Conservative treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas SCHOUMAN, MD

Role: PRINCIPAL_INVESTIGATOR

AP-HP - Hôpital Pitié-Salpêtrière

Locations

Explore where the study is taking place and check the recruitment status at each participating site.