Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Rate of fracture healing 12 months after fracture fixation
研究概览
简要总结
Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.
详细描述
The objective of this prospective PMCF study is to collect data to confirm safety, performance and clinical benefits of the Zimmer Natural Nail (ZNN) Bactiguard Retrograde Femoral Nail (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.
The primary endpoint is the assessment of performance by analyzing fracture healing.
The secondary endpoints are the assessment of safety, clinical benefit and post-op fracture related infection (FRI). Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Clinical benefit will be assessed by recording patient-reported outcome measures (PROMs). FRIs will be classified according to the updated diagnostic algorithm defined by the FRI Consensus Group.
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
- •Patients must be 18 years or older.
- •Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling / high energy trauma followed by definitive treatment by intramedullary nail) can also be included.
- •Patient has been or is scheduled to be treated with the ZNN Bactiguard System Retrograde Femoral Nail.
- •Patient must be able and willing to complete the protocol required follow-up.
- •Patient must have a signed EC approved consent.
- •Patients capable of understanding the surgeon's explanations and following his instructions.
排除标准
- •Skeletally immature patients
- •A medullary canal obliterated by a previous fracture or tumor
- •Bone shaft having excessive bow or a deformity
- •Lack of bone substance or bone quality, which makes stable seating of the implant impossible
- •All concomitant diseases that can impair the operation, functioning or the success of the implant
- •Insufficient blood circulation
- •Infection
- •Patient is unwilling or unable to give consent.
- •Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, alcohol/drug addiction, known to be pregnant or breast feeding).
- •Patient anticipated to be non-compliant and/or likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study).
- •Not expected to survive the duration of the follow-up program
研究组 & 干预措施
ZNN Bactiguard Retrograde Femoral Nail
Patients implanted with a ZNN Bactiguard Retrograde Femoral Nail for fixing and stabilizing a femoral fracture.
干预措施: ZNN Bactiguard Retrograde Femoral Nail (Device)
结局指标
主要结局
Rate of fracture healing 12 months after fracture fixation
时间窗: 3, 6, and 12 months after fracture fixation
Fracture healing is assessed with x-ray imaging and clinical examination. Radiographic Union-Scale in Tibial fractures (RUST) score adapted for the femur, A/P and lateral views. Range: 4 - 12. Fracture healing is defined as RUST scores greater than or equal to 6. Fix-IT score (clinical examination). Range 0 - 12, higher scores indicate better limb function.
次要结局
- EQ-5D-5L score (patient's quality of life)(pre-surgery (retrospectively), 3, 6, and 12 months after fracture fixation)
- Oxford Knee Score (limb function)(3, 6, and 12 months after fracture fixation)
- Adverse events frequency(12 months after fracture fixation)
- Rate of fracture-related infections(12 months after fracture fixation)