Short and Medium Term Postoperative Complications After Hallux Valgus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 479
- 试验地点
- 2
- 主要终点
- Onset complication within 1 year after the intervention
研究概览
简要总结
The aim of this study is to make a precise inventory of the complications that may occur postoperatively in the more or less long term in a cohort of patients who should benefit from surgical management of Hallux Valgus.
详细描述
Hallux Valgus surgery is one of the most common foot surgeries. The surgical procedure itself has evolved a lot and is now, in almost all cases, on an outpatient basis with greatly improved pain management.
However, various postoperative complications, more or less severe and more or less long term, can worsen the final result. The literature describing these complications comes mainly from meta-analysis, retrospective studies or studies targeting a particular type of complications.
As a result, there are few complete and objective descriptions of these complications.
In addition, studies reporting postoperative consequences always assess the "serious" long-term complications responsible for a poor functional outcome, primarily the recurrence of the initial deformity, defined as surgical failure. It seemed relevant to try to assess early complications, "less serious", not necessarily worsening the final result but directly impacting the postoperative recovery period.
The evaluation of this recovery period and the length of time off work based on these "less severe" complications could improve the quality of surgical management of hallux valgus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Patient with medical insurance.
- •Patient who recieved information about study and signes a consent to participate in the study.
- •Major patient requiring surgical management of a Hallux Valgus.
排除标准
- •Minor patient.
- •Patient participating in another interventional study.
- •Patient with one of the following pathologies: Rheumatoid arthritis, haemophilia, inflammatory rheumatism or neurological spasticity.
- •Patient to undergo a one-step bilateral Hallux Valgus surgical treatment (surgery of both feet on the same day).
- •Patient refusing to sign the consent form.
- •Patient for whom it is impossible to give informed information.
- •Patient under the protection of justice, under curatorship ou under tutorship.
结局指标
主要结局
Onset complication within 1 year after the intervention
时间窗: 1 year
Collection of the type of complication and its degree of severity (Clavien Dindo classification)
次要结局
- Evaluation of patient satisfaction(2 years)
- Onset all complications within 2 years after the intervention(2 years)