Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- AOFAS Score
研究概览
简要总结
This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows:
- To assess functional clinical score's evolution,
- To evaluate patient's satisfaction
- To confirm safety of varisation staples The target population for this study was any adult patient implanted with VEOFIX varisation staples in their intended uses between 15/02/2021 and 15/05/2021.
Patients were implanted and followed as per standard of care led in the investigational site.
The following regulation and guidelines were followed for this investigation:
- Standard ISO 14155:2020 "Good Clinical Practice"undirectly applicable;
- Regulation (UE) 2016/679 (RGPD) ;
- Regulation (UE) 2017/745 (MDR) ;
- MEDDEV 2.12.1;
- Local regulation (loi " jardé ", loi " informatique et libertés "). As per its design, the investigation is considered as involving human beings, and therefore require submission to an ethic committee or declaration to a Competent Authority (ANSM) and CPP. This study was registered on CPP (CPP Ile de France VII).
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
- •Man or woman
- •Major patient on the date of surgery
- •Patient with foot pathology requiring Akin osteotomy
- •Patient not opposed to the collection of data
排除标准
- •Patient unable to understand and follow the postoperative instructions
- •Patient with a contraindication to the use of the implant
- •Non-implanted patient with a varisation staple
结局指标
主要结局
AOFAS Score
时间窗: 3 and 12 months
To confirm the performance of varisation staples in conservative surgery of Hallux Valgus, according to the indications covered by the CE Marking (Akin's osteotomy) and according to the surgeon's current practice investigator. The scores range from 0 to 100, The average preoperative score was 50 to 60 points. Post-operatively, a score of 80 points is a good post-operative result, with the patient experiencing no or low levels of residual pain and full or partial recovery of joint function. The AOFAS Score is considered excellent between 90 and 100 points, good between 80 and 89, fair between 60 and 79, and poor below 60 points.
次要结局
- Patient Satisfaction(3 and 12 months)
- Number of Complications Observed During the Clinical Investigation(12 months)