Prospective Observational Study of Minimally Invasive Fixation of Thoracolumbar Fractures With the Fracture Fixation System S4, Performed With the Fracture Reduction Instrumentation FRI (FRIFIX)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Anterior wedge angle (AWA)
研究概览
简要总结
Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. Depending on the type of injury there are various methods available to stabilize the spine. The proposed study should clarify whether the combined reduction and fixation with a minimally invasive approach can actually be done with the same precision as in a conventional approach. The primary endpoint of this investigation is the monosegmental anterior wedge angle (AWA), and its maintenance over the first 6 postoperative weeks. It is the aim of the study to gather key radiological, clinical and subjective patient outcome parameters for its patient population that will allow to compare the results to a historical group of patients. The study design is non-interventional, prospective, open,and multicentric.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Minimum age of the patients of 18 years
- •Indication for operative treatment of fractures of the thoracic or lumbar spine
- •Singular A3.1-3 fractures according to the AO classification system
- •Declaration of consent in participation in this study and willingness to the treatment according to the study protocol
- •Physical and mental ability to meet the clinical and radiological follow-up plan
排除标准
- •Additional severe trauma, that makes survey of the patient difficult or impossible influence the results of the fracture treatment significantly
- •Additional trauma or fractures of the spine
- •Other serious conditions complicating participation in the study
- •Systemic or local infections
- •Pregnancy or planned pregnancy
- •Neurological deficits
- •Severe blood coagulation disorders diagnosed preoperatively
- •Intake of preoperatively anticoagulants
- •Osteoporosis
- •Bone metabolism disorders
- •Laminectomy necessary during surgery results in exclusion of the patient either
结局指标
主要结局
Anterior wedge angle (AWA)
时间窗: 6 weeks
次要结局
- Blood loss of the patient during surgery to stabilize the spine fracture(intraoperative)
- OP duration(intraoperative)
- Adverse events(Intraop and Postop)
- VAS Spine Score(3 days and 6 weeks)
- VAS pain score(3 days and 6 weeks)
- accompanying pain medication (or "self medication")(6 weeks)
- patient satisfaction with operational results(6 weeks)
- Hospital length of stay(discharge)