Complications and time required for surgical access with retromandibular transparotid and anteroparotid transmasseteric approaches in management of mandibular condylar fracture: A prospective randomised clinical study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complications and time required for each approach
研究概览
简要总结
25 to 45% of all the mandibular fractures are mandibular condylar fractures. The reason for the high incidence of condylar fractures is the peculiar anatomy of the mandible which ensures dissipation of forces along the bone allowing the weakest part of the condylar neck to fracture, thus preventing transfer of forces to the Cranium. Optimal osteosynthesis of such a fracture can be attained only by rigid internal ï¬xation after anatomic reduction. Studies by Ellis and Throckmorton published in 2000 conclude that patients who had ORIF had better restitution of condyle position and reinforcement of their fractured condylar processes. Patients who underwent closed reduction had displacement of the condylar process in the coronal plane, which persisted for up to 1 year, and had a signiï¬cant shortening of the mandibular ramus on the fractured side though bite forces did not show any signiï¬cant difference. To get direct vision of the fractured ends and mobilization of the displaced segments it is essential to gain complete exposure of the surgical field. Distance between the incision line and fracture level often necessitates excessive retraction of tissues resulting in nerve injuries and tissue damage. Appropriate choice of surgical approach gains importance in reducing the post operative complications especially while dealing with less accessible fracture sites like the sub-condylar region. Conventional exposure techniques like preauricular, submandibular, intraoral, and retromandibular incisions are the most commonly used access routes for the ORIF of a subcondylar fracture as endoscopes are yet to gain popularity in India. The intraoral route although desirable as it avoids facial scarring provides limited exposure for manipulation and fixation of the fracture site. Therefore the extra oral route is the most commonly selected one. However, each of these incision have varying degrees of complications reported due to the proximity to two vital structures namely the facial nerve and the parotid gland. The retro-mandibular approach described by Hinds and Girroti in1967 has been the most popular, as it involves a minimal working distance between the incision and the fracture. While using a retromandibular incision, the approach to the fracture site can be either through the parotid gland, as in the retromandibular transparotid approach, or the parotid maybe bypassed by use of the retromandibular transmasseteric anterior parotid (TMAP) approach. Here, we will try to compare two most popular variations of retromandibular approach that is – retromandibular transparotid approach; retromandibular anteroparotid transmasseteric approach. The purpose of this study will be to compare the time required to expose the condylar fracture site and also the rate of complications encountered on using different incisions to access the fracture site for the open reduction and internal ï¬xation of condylar fractures. The parameters evaluated are: time required to expose the condylar fracture site and the occurrence of salivary ï¬stula, infection, and injuries to the seventh cranial nerve.
Clinical Significance of the Study:
This study will help in decision making regarding the choice of approach between the Retromandibular Transparotid and Anteroparotid Transmasseteric approach based on the ease of surgical access and incidence of complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Participants in the age group of 18 – 60 years.
- •Participants with unilateral/bilateral condylar fractures indicated for open reduction.
- •Participants with unilateral/bilateral condylar fractures along with other concomitant fractures of mandible indicated for open reduction.
- •Participants who have sustained fracture in the past two weeks.
- •Subject willingness to participate in the study.
排除标准
- •Participants with history of uncontrolled diabetes mellitus, prolonged steroid therapy, compromised immunity and associated bone pathology.
- •Intracapsular Condylar fracture.
- •Undisplaced fractures of Mandibular Condylar fracture.
- •Patients with high condylar fractures.
- •Patients who have undergone open reduction and internal fixation for condylar fractures previously.
- •Participants with tendency for keloid formation and those with contused lacerated wounds, abrasions or Avulsive soft tissue injuries around the area of extraoral incision.
- •(pre existing scar)
- •Presence of preinjury Facial nerve palsy.
结局指标
主要结局
Complications and time required for each approach
时间窗: Complications will be evaluated at post operative day 1 day 7 1 month and 2 months
次要结局
- time required for each approach(Intraoperatively after incision till exposure of fracture)
- Post operative swelling(At 1 weeks and 2 weeks postoperatively)
- Parotid fistula(At 1 week and 2 weeks)
