Short-term Results After Minimally Invasive Chevron Osteotomy for Hallux Valgus Correction in Comparison to the Open Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
研究概览
简要总结
By means of clinical satisfaction and clinical scores comparison of an open to a minimally invasive distal chevron osteotomy for correction of a hallux valgus deformity is performed.
详细描述
The aim of this study is to evaluate shortterm clinical outcome after a minimally invasive chevron osteotomy technique for correction of hallux valgus deformity in comparison to the open distal chevron technique. Patients undergoing a distal chevron osteotomy for correction of a hallux valgus deformity are assigned to one of the two groups. Survey is taken preoperatively, after 2, 4, 6 and 12 weeks postoperatively. Assessment of the clinical outcome measures in terms of the range of motion (ROM), Visual Analogue Scores (VAS) of pain, the American Orthopaedic Foot and Ankle Society (AOFAS) forefoot Score and a patient satisfaction score and a Life Quality score (SF 12) as well as the evaluation of the Charlson Comorbidity score is performed. It is hypothesized, that clinical outcome with the minimally invasive distal chevron osteotomy is superior to the open technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
after completion of data collection personal data is anonymized. Outcomes assessor adds up the scores without knowing the type of surgery. The principal investigator as well as the statistical investigator do receive the completed anonymized excel file for doing the statistical analysis
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
- •all patients undergoing hallux valgus correction by means of a distal chevron osteotomy
排除标准
- •surgery on the lesser rays of the same foot
- •mental illness with impossibility to follow the postoperative protocol
研究组 & 干预措施
open distal chevron osteotomy
Hallux valgus correction is provided by using the traditional open distal v-shaped chevron osteotomy.
干预措施: open distal chevron osteotomy (Procedure)
minimally invasive distal chevron osteotomy
Hallux valgus correction is provided by using a minimally invasive distal v-shaped chevron osteotomy.
干预措施: minimally invasive distal chevron osteotomy (Procedure)
结局指标
主要结局
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
时间窗: Change of the foot circumference at the level of surgery from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome and therefore changes of the foot circumference at the level of surgery is assessed for both techniques to specific time points by measuring the foot circumference at the level of surgery (measurement in centimeter).
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
时间窗: Change of the scores from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome is assessed for both techniques with a clinical score to specific time points. AOFAS Hallux etmatarsophalangeal -interphalangeal Scale \[maximum 100 points, minimum 0 points - higher scores mean better outcome\]
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
时间窗: Change of the score from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome is assessed for both techniques with clinical a score to specific time points. JSSF Hallux metatarsophalangeal -interphalangeal Scale \[maximum 100 points, minimum 0 points - higher scores means better outcome\]
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
时间窗: Change of the SF 12 score from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical general situation is assessed for both techniques to specific time points by using the SF12 Life Quality Score \[maximum 47 points, minimum 0 points - higher scores mean better clinical situation\]
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
时间窗: Change of the VAS from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome and therefore the pain level is assessed for both techniques to specific time points by using the Visual Analogue Score for pain \[0-10\])
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
时间窗: Change of the range of motion and therefore the clinical outcome from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome is assessed for both techniques to specific time points by assessing the Range of motion (normal range 70-0-45 degrees)
次要结局
未报告次要终点
研究者
Dr.Gerhard Kaufmann
Gerhard Kaufmann MD, Clinical Professor
OFZ Innsbruck