Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 7
- 主要终点
- Maximal mouth opening (in mm) at 3 months
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Open treatment (Procedure)
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
干预措施: Closed treatment (Other)
结局指标
主要结局
Maximal mouth opening (in mm) at 3 months
时间窗: 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
次要结局
- Maximal mouth opening (in mm)(3 weeks (+/- 7 days), 6 weeks (+/-7 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment)
- Maximal mandibular protrusion (in mm)(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)(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(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(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(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(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)(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(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(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(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(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(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(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(Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12)