A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of CONQUEST FN for the Treatment of Intracapsular Femoral Neck Fractures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Reoperation Rate at One Year Post-operation
研究概览
简要总结
The purpose of this study is to assess the reoperation rate of fractures that have occurred at the neck of the femur that are treated with the CONQUEST FN Femoral Neck Fracture System. The CONQUEST FN Femoral Neck Fracture System is approved for use by the United States Food and Drug Administration (FDA). It consists of a stainless steel plate and up to three (3) screws intended to treat both non-displaced and displaced fractures to the femoral neck.
详细描述
The CONQUEST FN™ represents the next generation femoral neck fracture system designed to offer better intra-operative reduction control with the assurance of eliminating device failure modes. This system is dedicated to treating both non-displaced and displaced intracapsular fractures of the femoral neck. It is a dynamic locked implant system that provides multiple points of fixed angle support with continuous compression across the fracture site, ensuring bone-on-bone contact during the fracture union process. The continuous fracture site compression and post-operative reduction maintenance is accomplished with the incorporation of telescoping compression screw technology. The novel system empowers surgeons to address the current surgical challenges and often unfavorable patient outcomes and high re-operation rate associated with the current treatment options for intracapsular femoral neck fractures.
This study will evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the CONQUEST FN Femoral Neck Fracture System at one year post-operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must be 18 years of age or older
- •Must provide written informed consent
- •Willing to make all required study visits for one year post-operation
- •Subject has experienced a displaced or non-displaced intracapsular femoral neck fracture and is scheduled for repair using the CONQUEST FN Femoral Neck Fracture System.
排除标准
- •Subject with known sensitivity or allergies to stainless steel
- •Subject with fracture occurring more than 7 days prior to surgery
- •Subject has more than one fracture on the hip requiring surgery
- •Subject is considered obese by a Body Mass Index > 40 at the time of surgery
- •Therapy with another investigational agent within thirty 30 days of screening
- •Subject has emotional or neurological condition that precludes cooperation and compliance
- •Subject has undergone previous surgery on hip.
- •Subject has severe bow of the target hip or gross distortion of the femur.
- •Current systemic therapy with cytotoxic drugs
- •Subject has a physical condition that 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).
研究组 & 干预措施
Control femoral neck fracture system
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
干预措施: CONQUEST FN Femoral Neck Fracture System (Device)
结局指标
主要结局
Reoperation Rate at One Year Post-operation
时间窗: 1 year
Reoperation for any reason from time of implantation to one-year post operation
次要结局
- Number of Participants With Intraoperative Complications(7 days)
- Timed Up and Go (TUG)(6 Weeks, 3 Months, 6 Months, and 1 year)
- Active Straight Leg Raise (ASLR) Assessment: Evaluation Score(6 Weeks, 3 Months, 6 Months, and 1 year)
- Number of Participants With Construct Failure(6 months post-operative)
- Length of Hospital Stay(During hospitalization)
- Classification of Quality of Fracture Reduction(Operative, 6 weeks, 3 months, 6 months, and 1 year)
- Visual Analogue Scale (VAS) for Pain(Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year)
- Quality of Life - EQ-5D-5L(Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year)