Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail With Anterior Support Screw (AS2) Versus Conventional Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- Number of Patient With and Without Excessive Lag Screw Sliding Distance
研究概览
简要总结
The purpose of this study is to compare reduction positon maintenance rate at 3 weeks post-operatively between patients operated with Anterior Support Screw (AS2) and without AS2 technique in RCT setting. Total 240 cases(each arm 120 cases) will be enrolled at maximum 15sites, total study duration is 22months.
详细描述
Objective： To compare fracture reduction maintenance rate at 2-3weeks post-operatively between patients operated with AS2 (investigational group) and patients operated without AS2 (Control group) using same implant system (ZNN CM Asia, Zimmer Biomet).
Endpoint： Primary： The rate of reduction position maintenance at 2-3 weeks post-operatively. Secondary： Surgery time / fracture type / postoperative reduction position / CT assessment / Safety information
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
(Investigational group) or ZNN CM Asia without AS2 technique (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using a blocked randomization procedure. The block size will not be disclosed to the sites, and the doctor or other health care professional will not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria.
- •Eligible for intramedullary nailing.
- •Fracture type is classified as 3-partB or 4-part fracture in 3D-CT (Three Dimensional Computed Tomography) classification (Nakano), and combination with a subtype P in lateral classification (Ikuta) at preoperative CT (Computed Tomography) assessment.(In the case of classified in radiograph (X-ray) at preoperative: Classified as Type 4 or Type 5 in Jensen classification, and combination of subtype P in lateral classification (Ikuta))
- •Japanese Male or female
- •> 20 years of age
- •Primary closed intertrochanteric fracture of the femur
- •Subjects willing to return for follow-up evaluations.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study.
- •Patient who cannot take CT image within 3 days and 2-3weeks after surgery.
- •Uncooperative patient or patient with neurologic disorders who are incapable of following directions.
研究组 & 干预措施
ZNN CM Asia with AS2 technique
Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.
Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw).
干预措施: Open Reduction and Internal Fixation (Procedure)
ZNN CM Asia with AS2 technique
Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.
Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw).
干预措施: ZNN CM Asia (Device)
ZNN CM Asia with AS2 technique
Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.
Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw).
干预措施: Anterior Support Screw (Device)
ZNN CM Asia without AS2 technique
Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.
干预措施: Open Reduction and Internal Fixation (Procedure)
ZNN CM Asia without AS2 technique
Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.
干预措施: ZNN CM Asia (Device)
结局指标
主要结局
Number of Patient With and Without Excessive Lag Screw Sliding Distance
时间窗: Postoperative 2-3 week
Number of patient was counted based on CT measurement results. Relative position of lag screw between CT images taken at both immediate and 2-3 weeks postoperatively was measured and recorded in value (e.g., 1.5 mm). This was called as "lag screw sliding distance". Four millimeter was set as threshold to define success and failure. Less than 4mm of lag screw sliding distance was recognized as Success and equal to or more than 4mm of lag screw sliding distance was recognized as Failure.
次要结局
- Intraoperative Safety(Intraoperative)
- Surgery Time(Intraoperative, an average of 1 hour)
- Image Assessment Using Computed Tomography (CT)(2-3 weeks postoperatively)