NCT01693367终止4 期
A Multi-Center Randomized Controlled Pilot Study of Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
AO Innovation Translation Center24 个研究点 分布在 4 个国家目标入组 5 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 24
- 主要终点
- Western Ontario and McMaster Universities Index (WOMAC)
研究概览
简要总结
The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years and older
- •Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur fractures above a total knee arthroplasty
- •Ability to walk independently prior to injury
- •Eligible for treatment with ORIF of the distal femur with a large fragment locking plate (LISS, LCP)
- •Willing and able to comply with post-operative protocol and return for follow-up.
- •Ability to understand the content of the patient information / informed consent form and participate in the clinical investigation
- •Signed informed consent
排除标准
- •Additional ipsi- or contralateral lower extremity fracture
- •Any kind of implant at the ipsilateral proximal femur
- •Pre-existing malunion or nonunion of the ipsilateral lower extremity
- •Segmental bone defect requiring bone grafting
- •More than 4 weeks between injury and surgery
- •Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)
- •Polytrauma
- •Active malignancy
- •Any not medically managed severe systemic disease
- •Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- •Pregnancy or women planning to conceive within the study period
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
结局指标
主要结局
Western Ontario and McMaster Universities Index (WOMAC)
时间窗: 12 months after surgery
To assess pain, stiffness, and physical function
次要结局
- Timed Up-and-go Test (TUG)(12 weeks ± 7 days, 6 months ± 30 days)
- Quality of Life (EuroQol-5D)(Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery)
- Range of Motion (ROM)(6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery)
- Full Weight-bearing Status(weekly measurement at home)
- WOMAC(Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery)
研究者
研究点 (24)
Loading locations...
相似试验
终止
不适用
Dynaloc for Treatment of Femoral Neck FracturesFemoral Neck FractureNCT02030431Aarhus University Hospital150
终止
不适用
Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric FracturesHip FracturesNCT02345369Bassett Healthcare3
已完成
不适用
The Effect of Dynamic and Rigid Tape Application on the Asymmetry of the Lower LimbsMuscle WeaknessNCT04345224John Paul II University in Biała Podlaska90
已完成
不适用
Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial EmbolizationPeripheral Arterial DiseaseNCT05391399Shanghai Shenqi Medical Technology Co., Ltd121
尚未招募
不适用
Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck FracturesFracture of Femoral NeckNCT06713291Chinese PLA General Hospital1,150