Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Reduction of the Patient's Pain and Restoration of Walking
研究概览
简要总结
This clinical investigation was led as a post-marketing clinical follow-up study conducted as part of standard care with an additional, non-invasive, non-invasive procedure (Case 4.1) ambispective, multicentre, open-label, non-comparative.
The primary objective of this study is to evaluate the reduction in patient pain and the restoration of walking. The study will also collect performance and safety data to assess the subject's outcomes and functional status.
The target population for this study was any adult patient implanted with FAST screws, FAST plates, Toe FAST and VEOFIX screws between november 2021 and october 2022.
The investigation will be conducted in accordance with the investigation protocol, the laws and regulations (including the Medical regulations (including the Medical Devices Regulation 2017/745) and the ISO 14155:2020, as well as in accordance with the ethical principles described in the Declaration of Helsinki. The collection of personal data will also be compliant with RGPD 2016/679.
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
- •Male or female subject of legal age at the date of implantation;
- •Subject implanted with one or more implants: FAST Screw, FAST Plate, Toe FAST and VEOFIX Screw between November 2021 and October 2022;
- •Subject able to understand the information and instructions given by the investigator;
- •Subject with a social security affiliation.
排除标准
- •Vulnerable persons
- •People with contraindications (including pregnant women)
结局指标
主要结局
Reduction of the Patient's Pain and Restoration of Walking
时间窗: 12 months
The information will be collected through AOFAS (American Orthopaedic Foot and Ankle Society) score (\>80 points) at 12 months. This score is assessed using a questionnaire measuring the patient's pain, function and alignment of the foot. This score range from 0 (worst score) to 100 (best score). The score is interpreted as follows : Between 90-100 points : excellent results Between 80-89 points : good results Between 60-79 points : fair results Less than 60 points : poor results This score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points.
次要结局
- Survival Rate(12 months)
- Foot Bone Consolidation(12 months)
- Patient Satisfaction(12 months)
- Adverse Event(Peroperative to 12 months)