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临床试验/NCT05128851
NCT05128851Unknown不适用

Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Arthroscopic Treatment of Knee Intraarticular Lesions.

Centre of Postgraduate Medical Education2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
KOOS

研究概览

简要总结

This study will compare Hight Tibial Osteotomy with or without arthroscopically repair intra-articular knee lesions in patients with early stages of Osteoarthritis.The purpose of this study is evaluate if addition of arthroscopy to HTO provides better clinical, radiological and laboratory outcomes.

详细描述

Intraarticular knee lesions are often in patients with early stages of osteoarthritis. The most frequent findings are degenerative meniscus/meniscal tears and cartilage degeneration. Degenerative meniscal lesions or meniscal tears are often incidental findings without any complains from patients. In the current literature there is no evidence for good clinical outcomes after arthroscopically treatment degenerative meniscus. Cartilage injuries are common in osteoarthritic knee and depending on grading of chondromalacia are usually treated by microfractures. By this time the choice of performed surgery depends on surgeons personal assessment. The investigators believe that concomitant intraarticular procedures added to HTO will provide better clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination
  • Intraarticular lesions in MRI
  • Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests

排除标准

  • no informed consent to participate in the study
  • age under 18 years or above 65
  • multilligament injury or single plane knee instability
  • another musculoskeletal disorders in lower limb
  • lower limb deformity requiring axis correction below 4o or above 12.5o • joints inflammatory diseases
  • ASA score > II

结局指标

主要结局

KOOS

时间窗: 24 months

Knee Injury and Osteoarthritis Outcome Score

VAS

时间窗: 24 months

Visual Analog Scale

Blood test

时间窗: 12 weeks,

no inflammatory reaction - CRP, Il-6, CTx

IKDC

时间窗: 24 months

International Knee Documentation Committee - Subjective Knee Evaluation Form

次要结局

  • Kinematic MRI with [chondrogram](24 months)
  • X-ray - Baldini projection(24 months)

研究者

发起方
Centre of Postgraduate Medical Education
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rafał Kamiński

Chair of Division

Centre of Postgraduate Medical Education

研究点 (2)

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