NCT05483387招募中4 期
Prospective Post-market Clinical Follow-up Study of the HBS 2 Resorb Mg in Patients With Intra- and Extraarticular Fractures, Pseudarthroses and Arthrodesis of Small Bones and Bone Fragments.
KLS Martin2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Bony Fusion (Change)
研究概览
简要总结
This study is a multi-centre, prospective, clinical observational study to evaluate the CE-marked HBS 2 Resorb Mg screws under routine conditions. The device will be used according to its intended use. The data collected for this study does only include measurements which are standard of care.
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 is 18 years and older
- •Patient is undergoing surgery with HBS 2 Resorb Mg
- •Written informed consent obtained for the treatment
- •Treatment of intra-articular and extra articular fractures and pseudarthroses of small bones and bone fragments as well as arthrodeses in the treatment of:
- •Scaphoid fractures and scaphoid pseudarthroses
- •Proximal radius head fractures
- •Fractures of the radial styloid process
- •Fractures of the ulnar styloid process
- •Metacarpal fractures
- •Metatarsal fractures
排除标准
- •Any not medically managed severe systemic disease
- •Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
- •Pregnancy or women planning to conceive within the study period
- •Persons who are legally detained in an official institution
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- •Skeletally immature
- •Intraoperative decision to use implants other than the device under investigation
结局指标
主要结局
Bony Fusion (Change)
时间窗: 6 weeks, 12 weeks, 6 month and 12 month after surgery
The primary endpoint of the study is the fusion rate of the bone. After the onset of bony fusion, the implant no longer fulfils any function, and it should be resorbed.
次要结局
- Surgical revisions(YES/NO)(6 weeks, 12 weeks, 6 month and 12 month after surgery)
- Secondary displacement and breakage of the implant (YES/NO)(6 weeks, 12 weeks, 6 month and 12 month after surgery)
- Clinical outcome(6 weeks, 12 weeks, 6 month and 12 month after surgery)
- Early corrosion phenomenon(YES/NO)(6 weeks, 12 weeks, 6 month and 12 month after surgery)
- Deep infection(YES/NO)(6 weeks, 12 weeks, 6 month and 12 month after surgery)
- Radiolucency(YES/NO)(6 weeks, 12 weeks, 6 month and 12 month after surgery)
研究者
研究点 (2)
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