跳至主要内容
临床试验/NCT02642848
NCT02642848Unknown不适用

Clinical Outcomes of Open Wedge High Tibial Osteotomy With Autologous Bone Marrow or Adipose-derived Stem Cell Therapy

Dongsik Chae2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
52
试验地点
2
主要终点
Knee score

研究概览

简要总结

The purpose of this research is to confirm the efficacy of cartilage regeneration (or stem cell transplant) simultaneously performed with high tibial osteotomy. Furthermore, as conventional microfracture surgery on injured cartilage has a disadvantage of the replacement by fibrocartilage, this research intends to prove the excellence over the conventional therapy by proving a hyaline cartilage regeneration of injured cartilage by stem cell.

详细描述

The prevalence rate of arthritis in medial knee joint is increasing with an increase in senile diseases and there are two main types of therapy: total knee replacement surgery and high tibial osteotomy. Generally, the elderly prefer total knee replacement surgery and younger people prefer high tibial osteotomy. High tibial osteotomy is a procedure to reduce pain and to prevent the progression of osteoarthritis by evenly dispersing excessive load on medial knee joint attributed to varus deformity on the overall knee joint through the correction of abnormal anatomical axis arising from degenerative changes in articular cartilage. The clinical outcomes of high tibial osteotomy are reported as favorable but this high tibial osteotomy has a limitation in terms of the regeneration of injured cartilage. Thus, a research to concurrently perform additional therapy for the regeneration of injured cartilage with the osteotomy was released. Microfracture surgery on injured cartilage, autologous chondrocyte implantation, autologous bone marrow injections and adipose derived stem cell injections are typical examples. However, there is not any solid proof for the excellence of concurrent therapy over a therapy using only the osteotomy in the regeneration of injured cartilage. Therefore, this research is designed to conduct a research to prove the excellence of the direct transplantation of stem cell into injured cartilage over the existing concurrent therapy in the regeneration of injured cartilage. Besides, this research intends to compare the cartilage regeneration capabilities of bone marrow and adipose-derived stem cell.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 15 or more to 65 years of age or younger Classification of degenerative arthritis: Kellgren-Lawrence grade I, III, III Arthritis lesion limited to medial knee joint Varus deformity of knee joint of 15 degrees or less BMI under 35

排除标准

  • More than 65 years of age Classification of degenerative arthritis: Kellgren-Lawrence grade IV Lesions of arthritis (Kellgren-Lawrence grade III, IV) found in lateral knee joint Varus deformity of knee joint more than 15 degrees BMI above 35 Operation history - Surgery of Microfracture and fracture, and ligament regeneration History of intraarticular injection of steroid and hyaluronic acid in the last 3 months

结局指标

主要结局

Knee score

时间窗: one year

MRI

时间窗: One year

Using MRI, evaluate cartilage conditions by ICRS grade

Arthroscopic finding

时间窗: One year

Using arthroscopy, evaluate degree of cartilage repair

次要结局

未报告次要终点

研究者

发起方
Dongsik Chae
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dongsik Chae

Assistant professor

Catholic Kwandong University

研究点 (2)

Loading locations...

相似试验