Depuy Synthes Lower Extremity Shaft Nail Registry (RFN-Advanced™ Retrograde Femoral Nailing System/ TN-Advanced™ Tibial Nailing System)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 8
- 主要终点
- Time to Union
研究概览
简要总结
The purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA) and TN-Advanced Tibial Nailing System (TNA) in participants who have experienced femoral or tibial fractures, respectively, requiring fixation and stabilization or who require a revision due to a malunion or a nonunion.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature adults age greater than or equal to (>=) 22 years (Retrograde Femoral Nail Advanced [RFNA], Tibial Nail Advanced [TNA]) and adolescents 12-21 years of age in which the growth plates have fused (TNA only)
- •Participant receives an RFNA and/or TNA based on a diagnosis of open or closed, unilateral or bilateral femoral shaft or distal femur fracture (RFNA); unilateral or bilateral tibial fracture (TNA); revision of malunion or nonunion of previous fracture, or impending pathologic fracture (RFNA only) that will be treated operatively as part of standard of care. In addition, the following will be included: a) RFNA only: femoral shaft or distal femur fracture can be periprosthetic (PPFx) fracture after total or unicondylar knee arthroplasty, or total or hemi hip arthroplasty requiring nail osteosynthesis
- •Participant (legally authorized representative if participant is a minor) voluntarily signs the Institutional Review Board (IRB)/ Ethics committee (EC) approved consent form
- •Participant must be able to read and understand questions and responses in an available translated language for patient reported outcomes (PROs)
排除标准
- •Participation in any other medical device or medicinal product study within the previous month. Participation in observational studies is allowed
- •In the opinion of the Principal Investigator, participant is unable to comply with the requirements of the Registry
- •Participant has known allergies to implant components
结局指标
主要结局
Time to Union
时间窗: Up to Week 56
Time to union will be reported. Union is defined as a combination of radiographic and clinical assessment, where union will be considered achieved based on radiographic images, and no pain at the fracture site indicative of nonunion.
Number of Participants with Union (Healing)
时间窗: Up to Week 56
Number of participants with union (healing) will be reported. Union is defined as a combination of radiographic and clinical assessment, where union will be considered achieved based on radiographic images, and no pain at the fracture site indicative of nonunion.
次要结局
- Pain Visual Analogue Scale (VAS) Score(From Week 6 up to Week 52)
- Quality of Life as Assessed by EQ-5D-5L Questionnaire Score: EQ VAS(From Week 6 up to Week 52)
- Weight Bearing Status(From Week 2 up to Week 52)
- Short Form 12-Item Health Survey (SF-12) Questionnaire Score(From Week 6 up to Week 52)
- Quality of Life as Assessed by European Quality of Life (EuroQoL) 5-Dimensions 5-Levels (EQ-5D-5L) Questionnaire Score: EQ-5D Descriptive System(From Week 6 up to Week 52)
- Number of Participants with Reoperation(From Week 2 up to Week 52)
- Mobility Assessment(Up to Week 56)
- Number of Participants with Revision Surgery(From Week 2 up to Week 52)