Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Antegrade Femoral Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Performance of the study device
研究概览
简要总结
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit of the study device and instrumentation when used for the temporary internal fixation and stabilization of femoral fractures and osteotomies.
This is a CE-marked device already available on the market and the aim of the study is to comply with the post-market surveillance requirements.
详细描述
This study is a multicentre, prospective, post-market clinical follow-up study on the Zimmer Natural Nail (ZNN) Bactiguard Antegrade Femoral Nails.
The primary endpoint for this study is the assessment of performance by analyzing fracture healing within 12 months after fracture fixation. Fracture healing will be analyzed radiologically by the RUSH score adapted to the femur and clinically by the Fix-IT score.
The secondary endpoint is 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.
Data will be collected at 6 weeks, 3 months, 6 months and 1 year after fracture fixation.
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
- •Patient must be 18 or older
- •Patient must have a signed EC-approved informed consent.
- •Patient must have a femoral fracture (open, closed, monolateral, or bilateral) requiring surgical intervention or osteotomy 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 Antegrade Femoral Nail
- •Patient must be able and willing to complete the protocol required for follow-up
- •Patients capable of understanding the surgeon's explanations and following his instructions
排除标准
- •Skeletally immature patients
- •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 to give consent.
- •Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, subjects with 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 the course of study)
- •Patients not expected to survive the duration of the follow-up program
结局指标
主要结局
Performance of the study device
时间窗: 12 months after fracture fixation
Analyzed as fracture healing 12 months after fracture fixation. Fracture healing will be analyzed radiographically and clinically. Radiographic healing is considered achieved when two or more cortices reach a score of two (2) on a version of the Radiographic Union-Scale in Tibial fractures (RUST) tool adapted for the femur, in A/P and lateral views. Clinical fracture healing will be assessed via the FiX-IT score.
次要结局
- Safety assesment(6 weeks and 3, 6, and 12 months after fracture fixation)
- Oxford Hip Score(3, 6, and 12 months after fracture fixation)
- Rate of fracture-related infections(6 weeks and 3, 6, and 12 months after fracture fixation)
- EQ-5D Health Questionnaire(3, 6, and 12 months after fracture fixation)