Metatarsophalangeal Arthrodesis of the Hallux : Observational Study Evaluating the Efficacy and Tolerance of Synthetic Methods Using Dorsal Plate and Large-diameter Screws
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Rate of bone fusion obtained with different types of osteosynthesis material (dorsal plate and large-diameter compressive screw)
研究概览
简要总结
The purpose of the study is to describe the rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation.
详细描述
The main objective of the study is to describe the rate of bone fusion obtained with the different types of osteosynthesis material: dorsal plate, large-diameter compression screw.
Patients will be divided into two groups:
- patient undergoing arthrodesis of the hallux with a large diameter screw (group A)
- patient undergoing arthrodesis of the hallux by plate (group B)
This is a prospective, cross-sectional, open, comparative, non-randomized, non-interventional, monocentric study on two methods of synthesis (large-diameter plate or screw) of hallux metatarsophalangeal arthrodesis. Patients will be managed in accordance with current practice, the choice of surgical strategy (percutaneous / open) being left to the discretion of the investigators.
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
- •Patient undergoing isolated first ray surgery (M1 only) of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach;
- •Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw;
- •Patient able to understand information related to the study and complete quality of life questionnaires;
- •Patient accepting study follow-up visits;
- •Patient having been informed and agreeing to participate in the study.
排除标准
- •Pregnant or breastfeeding women;
- •Patient undergoing lateral ray surgery;
- •Patient undergoing revision arthrodesis;
- •Patient with a loss of bone substance requiring a graft;
- •Patient suffering from chronic inflammatory disease;
- •Patient treated with long-term immunosuppressive or corticosteroid treatments;
- •Patient under guardianship or curatorship, or under a regime of deprivation of liberty.
结局指标
主要结局
Rate of bone fusion obtained with different types of osteosynthesis material (dorsal plate and large-diameter compressive screw)
时间窗: 4 months
Rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation, obtained with different types of osteosynthesis material: dorsal plate and large-diameter compressive screw
次要结局
未报告次要终点