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临床试验/NCT04719195
NCT04719195Unknown不适用

Comparison of Meniscus Extrusion Between Preoperative and Postoperative Medial Opening Wedge High Tibial Osteotomy by Using Ultrasonographic Assessment

The Catholic University of Korea1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年7月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
WOMAC(Western Ontario and McMaster University Arthritis Index ) pain scale

研究概览

简要总结

The purpose of this study is to measure the changes in the medial and lateral meniscus extrusion of the knee joint before and after surgery using ultrasound in patients who undergo medial opening wedge high tibial osteotomy, and examine the differences.

详细描述

High tibial osteotomy (HTO) is an established treatment method for medial compartment osteoarthritis with varus knee deformity in a relatively young patient group. Excellent outcomes of HTO have been reported. However, about 10-30% of patients are not satisfied with the results after surgery. After proximal tibial osteotomy, studies on the factors of dissatisfaction have been actively conducted, but studies on the medial and lateral meniscus extrusion, which can be the cause, are insufficient. The relationship between the prolapse of the medial meniscus and articular cartilage is already well known and is known as an important factor in the progression of arthritis. As such, the association between the knee joint with meniscus extrusion and the general knee joint has been studied, but the effect on the clinical outcome after proximal tibial osteotomy has not been studied. Therefore, in this study, the investigators are planning to investigate the differences in clinical outcomes such as the degree and change of medial and lateral meniscus extrusion through non-invasive ultrasound examination before and after surgery in patients who undergo medial open proximal tibial osteotomy.

This study will enroll the patients with knee medial compartment osteoarthritis of the knee joint who undergo open proximal tibial osteotomy. The degree of medial and lateral meniscus extrusion will be measured through ultrasound measurements before and after surgery. Also, demographic factors and radiographic measurements will be also investigated before and after surgery. In addition, preoperative, postoperative 3, 6, and 1 year clinical results including meniscus extrusion will be compared and judged, and the evaluation will be evaluated by an orthopedic surgeon who has not participated in the operation among registered researchers.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Adults over 20
  • Medial compartment knee osteoarthritis patients for Medial Opening Wedge High Tibial Osteotomy
  • Patients who are willing or able to follow doctor's instructions, including joint exercises
  • Patients who have received sufficient explanation for this clinical trial and agreed to participate

排除标准

  • Patients with secondary knee osteoarthritis
  • Patients with inflammatory arthritis or crystalline arthritis
  • Local infection to the lower extremities of the pain area, sepsis, or previous neurological abnormalities.
  • Patients with knee range of motion less than 90 degrees
  • Patients with BMI above 40

结局指标

主要结局

WOMAC(Western Ontario and McMaster University Arthritis Index ) pain scale

时间窗: changes from pre-operative WOMAC score at post-operative 3rd month, 6th month and 1 year

次要结局

  • Pain Visual Analogue Scale(changes from pre-operative VAS score at post-operative 3rd month, 6th month and 1 year)
  • SF-12(Short Form heath survey) score(changes from pre-operative SF-12 score at post-operative 3rd month, 6th month and 1 year)
  • EQ-5D(EuroQoL-5 Dimension)(changes from pre-operative EQ-5D score at post-operative 3rd month, 6th month and 1 year)
  • X-ray(changes from pre-operative weight bearing line ratio at post-operative 3rd month, 6th month and 1 year)
  • Knee range of motion(changes from pre-operative knee range of motion at post-operative 3rd month, 6th month and 1 year)
  • Ultrasonographic evaluation of medial and lateral meniscus extrusion(changes from pre-operative ultrasonographic evaluation of medial and lateral meniscus extrusion at post-operative 3rd month, 6th month and 1 year)

研究者

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

Yong In

Professor

The Catholic University of Korea

研究点 (1)

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