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临床试验/NCT05128864
NCT05128864Unknown不适用

Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Fulkerson Osteotomy

Centre of Postgraduate Medical Education2 个研究点 分布在 1 个国家目标入组 110 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
110
试验地点
2
主要终点
Biomechanics MRI

研究概览

简要总结

This study will compare Hight Tibial Osteotomy with or without Fulkerson Osteotomy performed on patients with early stages of Osteoarthritis with patellofemoral joint disorders. The purpose of this study is evaluate which type of osteotomy provides better clinical, radiological and laboratory outcomes.

详细描述

Progression of knee cartilage degenerative changes leads to necessary total knee arthroplasty in future, which is the most popular procedure for treating OA. HTO applied at early stages of osteoarthritis allow slow down cartilage degeneration process, but the choice of performed surgery depends on surgeons personal assessment. Patellofemoral Pain Syndrome often occurs with knee arthritis. Antero-medialisation of tibial tubercle is frequent procedures for patella maltracking. So far, both, HTO and Fulkerson osteotomy was performed separately, even if patient have symptoms from patellofemoral joint and OA. The investigators believe that simultaneously surgery of HTO and fulkerson Osteotomy provides better outcomes and significantly slow down knee degeneration.

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
  • 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
  • multi ligament 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

Biomechanics MRI

时间窗: 2 years

Patellofemoral Joints Biomechanics improvement measured

Biomechanics X-ray

时间窗: 24 months

Patellofemoral Joints Biomechanics improvement measured

次要结局

  • KOOS(24 months)
  • IKDC(24 months)
  • Tegner Lysholm(24 months)
  • SF-36(24 months)
  • VAS(24 months)
  • Blood test(6 weeks)

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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