The OmniMax MMF System: A Cohort Study for Clinical Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 3
- 主要终点
- Root Damage
研究概览
简要总结
OmniMax MMF system was designed as a device with faster application/removal time, less mucosal tissue overgrowth over the plates and screws, better tolerance for placement over prolong periods of time, better patient hygiene and a lower risk for further treatments secondary to root damage from the insertion of the screws, compared to the standard of care for maxillo-mandibular fixation and other hybrid systems. This clinical trial intends to highlight the clinical benefits of the OmniMax MMF system applied to patients undergoing repair of uncomplicated mandibular fracture(s) for whom OmniMax MMF system is used as a single mean for maxillo-mandibular fixation.
详细描述
The objective of this study is to highlight and evaluate the clinical benefits of OmniMax MMF system applied to patients undergoing repair of uncomplicated mandibular fracture(s). A total of 50 subjects involved in trauma events resulting in uncomplicated mandibular fracture(s) will be enrolled at up to 5 sites from 3 surgical subspecialties: maxillofacial surgery, ENT, and plastic surgery. Subjects considered for participation will receive OmniMax MMF system for maxillo-mandibular fixation for a period of 4 to 8 weeks. Incidence of root damage associated with screw insertion, time for implantation and removal of the device, oral hygiene during the maxillomandibular fixation period, mucosal overgrowth, gingival necrosis, post-operative pain, stability of the occlusion, fracture healing, patient overall satisfaction/compliance with length of treatment, incidence of glove perforation and accidental puncture, will be evaluated in all participants who remain in IMF post-operatively. Adverse Events associated with the use of OmniMax MMF system will also be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females
- •18 years of age or older
- •Able and willing to sign ICF and medical photography consent
- •Undergoing a surgical procedure to repair uncomplicated mandibular fracture(s) requiring open reduction internal fixation (ORIF) or closed maxillo-mandibular fixation (MMF)
- •Fracture repair done within 10 days after facial trauma
- •Use of OmniMax MMF system as a single mean for IMF (maxillary plate and mandibular plates together with no other device combined, such as Erich bars or IMF screws).
排除标准
- •General contraindications unfavorable for the use of MMF (psychological disorders, seizures disorders, airway compromise, immune-compromised patients, etc).
- •History of radiation therapy to the head or neck region.
- •Limited blood supply to the area of device application.
- •Insufficient quantity or quality of bone.
- •History of foreign body sensitivity.
- •History of previous use of bisphosphonates (i.e. alendronate, pamidronate, neridronate, olpadronate, ibandronate, risendronate, zolendronate).
- •Clinically active or latent infection.
- •Patients with less than 20 teeth.
- •Deciduous dentition.
- •Patients for whom the use of OmniMax MMF system would not be appropriate in judgment of the surgeon (i.e., excessive overjet or deep overbite).
- •Mandibular fracture pattern that could prevent the use of OmniMax MMF system for adequate reduction and stabilization (i.e., comminuted fractures, dental alveolar fractures).
结局指标
主要结局
Root Damage
时间窗: 6 weeks
Dental root damage can be caused from insertion of the screws at time of implantation. Some of these events may require further medical or surgical treatment
次要结局
- Time for Implantation of OmniMax MMF(Operative)
- Tissue necrosis and mucosal overgrowth(6 weeks)