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临床试验/NCT04288297
NCT04288297已完成不适用

Midterm Results After Minimally Invasive Distal Chevron Osteotomy: Comparison of Our Results to the Minimally Invasive Reverdin-Isham Osteotomy From a Systematic Review of the Literature.

Dr.Gerhard Kaufmann1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
radiological outcome after minimally invasive Chevron osteotomy in comparison to the minimally invasive Reverdin-Isham method presented in literature

研究概览

简要总结

This study analyses the Reverdin Isham procedure, which is the most popular minimally invasive surgical hallux valgus correction method and the minimally invasive chevron osteotomy, representing the standard technique of open surgery. It is hypothesized that the two techniques would show significant differences in regard to radiological outcome (Hypothesis 1), clinical outcome (Hypothesis 2) and development of radiological recurrence (Hypothesis 3).

详细描述

Multiple different surgical techniques have been established for hallux valgus surgery so far, each technique with its unique advantages and limitations. The distal chevron method is widely accepted as a surgical method for correcting mild to moderate hallux valgus deformities. Numerous publications presenting the radiological outcome of this surgical technique and the clinical outcome by means of well established score systems have been published and make this technique, today's benchmark in hallux surgery.

Due to scarring and decreased range of motion of the greater toe joint after open surgery and increasing patients' demands several minimally invasive techniques have been brought to public in the last few years. These techniques claim minor soft tissue damage and reduced surgical time. The efficiency and stability of correction, as well as the clinical outcome of these techniques have been discussed controversially. However, most studies present data from minimally invasive surgery without specific differentiation of the type of surgery and in regard to the clinical and radiological outcome.

Recently a prospective randomized study comparing the open versus the minimally invasive chevron technique has been published presenting data with comparable clinical and radiological outcome.

Given the above-mentioned lack of evidence it was the aim of the study to compare the results of two different minimally invasive techniques. The investigators analyzed the Reverdin Isham procedure, which is known as the technique, that made minimally invasive hallux surgery popular and the minimally invasive chevron osteotomy. It was hypothesized that the two techniques would show significant differences in regard to radiological outcome (Hypothesis 1), clinical outcome (Hypothesis 2) and development of radiological recurrence (Hypothesis 3).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients after minimally invasive distal Chevron osteotomy for hallux valgus deformity with a Minimum follow up of 24 months
  • patients with informed written consent for being analyzed
  • patients, of whom radiographs are available from preoperative throughout the follow-up time of 24 months

排除标准

  • patients under 18 years of age
  • pregnant patients, or women below the age of 50 ys, of whom the pregnancy status is not clear
  • patients with mental illness or patients, who cannot follow the required postoperative Treatment or controls
  • patients, who refuse to participate
  • patients, who are assigned to other clinical studies

结局指标

主要结局

radiological outcome after minimally invasive Chevron osteotomy in comparison to the minimally invasive Reverdin-Isham method presented in literature

时间窗: change from preoperative to 24 months postoperative (as it is presented in literature)

radiographic (Hallux valgus angle, Intermetatarsal articular angle and distal metatarsal articular angle measured in grades) with the minimally invasive Chevron osteotomy is evaluated. Data is collected from a consecutive Patient cohort treated at the investigator´s Department. A cohort of more than 50 patients will be assessed.

次要结局

  • clinical outcome after minimally invasive Chevron osteotomy in comparison to the minimally invasive Reverdin-Isham method presented in literature(change from preoperative to 24 months postoperative (as it is presented in literature))

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr.Gerhard Kaufmann

Dr. Gerhard Kaufmann, Principal investigator and Head of the Orthopaedic and Foot Center Innsbruck

OFZ Innsbruck

研究点 (1)

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