Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Affixus Natural Nail System Humeral Nail (Implants and Instrumentation)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Bone Union
研究概览
简要总结
A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.
详细描述
Study objective:
The objectives of this observational, prospective study with optional retrospective enrollment are to confirm safety, performance and clinical benefits of the Affixus Natural Nail System Humeral Nail and its instrumentation by analyzing adverse event records, fracture/osteotomy healing and functional outcome and adverse events.
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The performance and clinical benefits will be evaluated by assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects.
Study Endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 18 years or older and skeletally mature.
- •Patient must have either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing.
- •Patient has been or is scheduled to be treated with the Affixus Natural Nail System Humeral Nail.
- •Patient must be able and willing to complete the protocol required follow-up.
- •Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent. (An Institutional Review Board/Ethics Committee is group that has been formally designated to review and monitor medical research involving human subjects.)
- •Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study.
排除标准
- •Distal fracture involving the olecranon fossa.
- •Bone shaft having excessive bow or deformity.
- •A medullary canal obliterated by a previous fracture or tumor.
- •Active or previous infection.
- •Skeletally immature patients.
- •All concomitant diseases that can impair the functioning and the success of the implant.
- •Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent and following postoperative care instructions.
- •Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
- •Patient known to be pregnant or breast feeding.
- •Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study).
- •Patients who have any condition that would in the judgment of the investigator place the patient at undue risk or interfere with the study.
- •Not expected to survive the duration of the follow-up program.
结局指标
主要结局
Bone Union
时间窗: 12 months
The primary endpoint is bone union after 12 months since surgery. (Bone union defined as no pain or tenderness at the site, and strong enough to allow normal activities.)
次要结局
- EQ-5D-5L(12 months)
- Range of Motion(12 months)
- Adverse Events(12 months)
- Radiographic Findings(12 months)