Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 167
- 试验地点
- 5
- 主要终点
- Thoracic pain as assessed by numeric Rating Scale (NRS)
研究概览
简要总结
This is a prospective, multi-center, observational, cohort study involving skilled cardiothoracic surgeons who are experienced in implanting the treatment of non-flail chest rib fractures and the use of RibFix Blu Thoracic Fixation System.
详细描述
The objective of this study is to evaluate the benefits of surgical stabilization of rib fractures (SSRF) in patients with non-flail chest rib fractures using RibFix Blu Thoracic Fixation System when compared to non-surgical (analgesia and symptomatic management) treatment. The study will include up to 167 cases of non-flail chest rib fractures with 95 cases in non-surgical treatment group and 72 cases in the surgical group. Each center may enroll up to maximum 30 cases to permit the assessment of outcome across a variety investigators and clinical settings. Enrolment will be competitive among sites and closed as soon as a total of 167 cases are recruited.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Age 18 and above (inclusive)
- •Simple rib fracture with ≥ 3 consecutive ribs, and the broken ends showed clear displacements
- •Indicated for surgical repair of rib fractures using RibFix Blu Thoracic Fixation System or non-surgical treatment (analgesia and symptomatic management treatment)
- •Willing and able to complete scheduled follow-up evaluations as described in the study protocol
- •Has participated in the Informed Consent process and is willing and able to sign an Institutional Review Board or Ethics Committee (IRB/EC) approved Patient Information/ Informed consent Form (PICF)
排除标准
- •Flail chest rib fractures based on radiological or clinical findings
- •Previous rib fractures or pulmonary problems, requiring continuous oxygen use at home pre-trauma
- •Presence of any serious medical issues that placed patient in generally poor conditions such that he or she could not tolerate the surgery
- •Chest trauma associated with severe craniocerebral injury, abdominal organ injury, severe spinal injury, limb fracture, or pelvic fracture requiring long-term bed rest
- •Has serious medical disease that is a contraindication for general anesthesia, such as cerebral infarction, myocardial infarction and hemorrhagic syndrome
- •Any contraindications listed in the manufacturer's Instruction to use for RibFix Blu Thoracic Fixation System as per below:
- •Spanning a midline sternotomy
- •Active Infection
- •Foreign body sensitivity
- •Is known to be pregnant
- •Is a prisoner, known alcohol or drug user or mentally incompetent or unable to understand what participation in this study entails.
- •Participation in another surgical intervention that may influence any of the outcome parameters.
结局指标
主要结局
Thoracic pain as assessed by numeric Rating Scale (NRS)
时间窗: 2 weeks
Level of thoracic pain determined using a numeric Rating Scale (NRS). Thoracic pain will be determined using an 11-point Numeric Rating Scale (NRS) in which 0 implicates no pain and 10 the worst pain. If a subject is not able to provide a response to the level of thoracic pain,
次要结局
- Length of Hospital stay(12 weeks)
- Pulmonary function(2 weeks, 6 weeks and 12 weeks)
- Rate of Analgesic use(12 weeks)
- Number of Participants with respiratory complications(2 weeks, 6 weeks and 12 weeks)
- Quality of life using EuroQoL-5L(2 weeks, 6 weeks and 12 weeks)