A Prospective Study To Evaluate The FEMORAL NECK SYSTEM (FNS) In The Treatment Of INTRA-CAPSULAR FEMORAL Neck Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Re-operation rate
研究概览
简要总结
A post-market, prospective study to evaluate the reoperation rate of displaced and nondisplaced femoral neck fractures treated with the Femoral Neck System (FNS)™
详细描述
To evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the Femoral Neck System (FNS)™ at one year post-operation. The Femoral Neck System (FNS)™ represents a new generation of implants designed to improve outcomes in the treatment of femoral neck fractures. These implants offer a fixed angle construct and all of its mechanical advantages with regards to neutralizing shear and providing stability while not exerting a rotational malreduction force on the fracture. The FNS system has been shown to compare favorably to traditional fixed angle constructs in a cadaveric model
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
- •The subject must provide written informed consent
- •The subject must be eighteen (18) years of age or older.
- •The subject must be willing and able to make all required study visits including one (1) year post-operative follow-up.
- •The subject must be able to follow instructions.
- •Subject has experienced displaced or non-displaced intracapsular femoral neck fracture
排除标准
- •Subject with fracture occurring more than 7 days prior to the date of surgery
- •Subject has more than one fracture on target extremity.
- •Subject is obese as defined by a Body Mass Index (BMI) > 45 at the time of surgery.
- •Subject, in the opinion of the Investigator, has an emotional or neurological condition that preludes cooperation and compliance with the rehabilitation regimen.
- •Therapy with another investigational agent within thirty (30) days of Screening or planned therapy with another investigational agent during the course of the study.
- •Subject has a physical condition that, in the opinion of the Investigator, would preclude adequate implant support or impede healing (e.g. blood supply impairment insufficient bone quality or quantity, or an active, local or systemic infection). If this is identified at the time of surgery, the subject will be screen failed.
- •Subject has undergone previous surgery on the target hip.
- •Current systemic therapy with cytotoxic drugs.
- •Subjects with a history of poor compliance with medical treatment.
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
研究组 & 干预措施
Femoral Neck System (FNS) Participants
Participants who will undergo surgery to treat a fractured femoral neck using the FNS (Femoral Neck System)
结局指标
主要结局
Re-operation rate
时间窗: Year 1 post-operation
Re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the Femoral Neck System (FNS)™
次要结局
- Timed Up and Go (TUG) time(Week 6, Months 3, 6, and 12)
- European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Score(Baseline, Week 6, Months 3, 6, and 12)
- European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) - VAS (Visual Analogue Scale) Score(Baseline, Week 6, Months 3, 6, and 12)
- Visual Analogue Scale (VAS) for Pain Score(Baseline, Week 6, Months 3, 6, and 12)
- Number of Participants with Quality of Fracture Reduction(Baseline, Week 6, Months 3, 6, and 12)
- Active Straight Leg Raise (ASLR) Assessment Score(Baseline, Week 6, Months 3, 6, and 12)
- Number of Participants with Intraoperative complications(Baseline, Week 6, Months 3, 6, and 12)
- Radiographic outcomes including quality of fracture reduction(Baseline, Week 6, Months 3, 6, and 12)
- Number of Construct failure past 6 months(Months 6 and 12)
- Time to return to full weight-bearing(Week 6, Months 3, 6, and 12)
- Ambulatory status from pre-injury to study completion(Baseline, Week 6, Months 3, 6, and 12)
- Length of hospital stay(Week 6, Months 3, 6, and 12)
- Number of Hospital readmission for any reason(Week 6, Months 3, 6, and 12)