A Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 7
- 主要终点
- Number of complications within the first 3 months after surgery
研究概览
简要总结
In comparison to previous implants, the Femoral neck system (FNS) is an approved implant by the competent authorities (CE mark). It is designated to stabilize medial femoral neck fractures in a minimal invasive technique. The implant combines an angular stable device with screw in screw technology for rotational stability. Therefore the purpose of this focused registry is to investigate how the newly developed and approved implant called FNS is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome.
详细描述
All patients included are treated as per standard or care and followed up from the time point of enrollment until at least three months after surgery as described below. Data of a visit after 6 months and 12 months are collected if bone union according to the RUSH score is not complete after 3 or 6 months respectively or if the patient has persistent or increasing pain on the operated site.
Preoperative:
- Patient details
- Fracture Classification and comminution based on CT
- Pre-fracture HHS and EQ5D
- X-rays
Intraoperative:
- Surgery details
- Defined intraoperative complications
- Intraoperative fluoroscopy: hip ap (with leg 15° internally rotated) and lateral after reduction and after implant placement
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
- •Age 18 years and older
- •Diagnosis of a medial femoral neck fracture (AO/OTA 31-B1:3) with the need of a fixation using the FNS.
- •Ability to understand the content of the patient information/Informed Consent Form
- •Willingness and ability to participate in the registry according to the Registry Plan (RP)
- •Signed and dated Ethics Committee (EC)/Institutional Review Board (IRB) approved written informed consent
排除标准
- •Pathological fracture
- •Additional acute fracture
- •Any not medically managed severe systemic disease
- •Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
- •Pregnancy or women planning to conceive within the registry period
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry
结局指标
主要结局
Number of complications within the first 3 months after surgery
时间窗: 3 months
次要结局
- Harris Hip Score(Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery)
- Length of surgery(Surgery (Day 0))
- Time from injury to surgery(Surgery (Day 0))
- EQ5D-5L(Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery)
- Classification of the fracture(Pre-operatively (Day -1))
- Quality of reduction (Garden's alignment index and Lowell's criteria)(Surgery (Day 0))
- Fracture mechanism(Pre-operatively (Day -1))
- Radiological bone union (RUSH score)(6 weeks, 3 months, 6 months and 12 months after surgery)