A.L.P.S. Clavicle Plating System for Clavicle Fracture Fixation Post-Market Follow-up Study (Implants and Instrumentation)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 98
- 试验地点
- 10
- 主要终点
- Number of subjects with fracture healing
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 ALPS Clavicle Plating system for both the implant itself and the instrumentation used during surgery.
详细描述
The objectives of this observational, prospective study with optional retrospective enrollment are to confirm safety, performance and clinical benefits of the A.L.P.S Clavicle Plating System and its instrumentation by analysis of fracture healing, functional outcome and adverse events.
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events including re-operations. Relation of the events to implant, instrumentation and/or procedure should be specified.
The performance will be evaluated by assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient must be 18 years of age or older.
- •Patient must have a clavicle fracture requiring surgical intervention and be eligible for fixation by locking plate and screws.
- •Unilateral or Bilateral fractures.
- •Patient must be capable of understanding the doctor's explanation, following doctor's instruction, is able to and willing to complete the protocol required follow-up.
- •Patient must have a signed IRB/EC approved informed consent.
排除标准
- •Active infection.
- •Patients presenting conditions including blood supply limitations, insufficient quantity or quality of bone.
- •Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent, following postoperative care instructions.
- •Foreign body sensitivity where material sensitivity is suspected, testing is to be completed prior to implantation of the device.
- •Patient is a current alcohol or drug abuser
- •Patient is a prisoner
- •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)
- •Not expected to survive the duration of the follow-up program
研究组 & 干预措施
Treatment Group
The population target is all subjects suffering clavicle fracture suitable for open reduction and internal fixation by the A.L.P.S. Clavicle Plating System in accordance with the IFU.
干预措施: Clavicle open reduction and internal fixation (Device)
结局指标
主要结局
Number of subjects with fracture healing
时间窗: 12 months
Number of subjects with fracture healing will be assessed through 12 months follow-up. Radiologic fracture healing is defined as: Bridging callus or no visible fracture lines on AP and 15-45° cephalic oblique radiographs.
次要结局
- Frequency and Incidence of Adverse Events (Safety)(12 months)
- Range of Motion - Total shoulder motion(12 months)
- Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 12 months follow-up(12 months)
- Euroqol Patient Quality of life measured at 12 months follow-up (EQ-5D-5L)(12 months)