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临床试验/NCT05912998
NCT05912998尚未招募不适用

Comparative Study Between Autologous Adipose Tissue Graft With Hyaline Catilage Versus Microfracture for Treatment of Articular Cartilage Defects

Assiut University0 个研究点目标入组 105 人开始时间: 2023年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
105
主要终点
Clinical assessment of International Knee Documentation Committee (IKDC) scores

研究概览

简要总结

Knee arthroscopy using standard portals will be performed in three groups. Complete evaluation of all intra -articular structures will be performed followed by accurate localization of the cartilage defect and measurement of its dimensions. The cartilage lesion grading according to the International Cartilage Repair Society system (ICRS). The patients assigned for the first group will have Liposuction through a minor 1 cm incision on the abdomen to obtain adequate amount of emulsified adipose tissues (50 - 60 cc). Autologous adipose tissue will be mixed with autologous hyaline cartilage obtained from non-weight bearing areas of the knee in prepared mold. The graft will be mixed with fibrin glue and left to solidify a little. After obtaining the fashioned graft from the mold it will be fixed in to the defect site by fibrin glue through mini open approach and stability of the implant fitted in the site will evaluated by gentle cycling of the joint. During the graft preparation, a high tibial osteotomy will be performed. Patients assigned for the second group will have microfracture in association with open wedge high tibial osteotomy. Patients assigned for the third group will have open wedge high tibial osteotomy. Standard titanium T locked plate will be used to fix the open wedge osteotomy in the three groups.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age group 18 to 60 years old.
  • Cartilage defect size range 2-5 cm
  • Outer Bridge classification II & III.
  • Single full thickness symptomatic femoral condyles ulcer.
  • Varus deformity of the affected knee 50 - 100.

排除标准

  • Advanced knee osteoarthritis.
  • Knee range of motion less than
  • Ligamentous injury of the affected knee.
  • Recent intra articular injection of any type with in last 6 months.
  • Fracture around the knee.
  • Inflammatory joints disorders.
  • Immunocompromised patients.
  • Body mass index < 35
  • Valgus deformed knee any degree
  • Sever varus deformed knee < 10 0

结局指标

主要结局

Clinical assessment of International Knee Documentation Committee (IKDC) scores

时间窗: one year

次要结局

未报告次要终点

研究者

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

Mahmoud Abdelgaliel Mohamed

Dr

Assiut University

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