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临床试验/NCT03147495
NCT03147495已完成不适用

Research on the Association Between the Inclination of the Proximal Tibiofibular Joint Surface and Medial Compartment Knee Osteoarthritis

113th Hospital of Chinese People's Liberation Army1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2017年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
The Tibial Inclination Angle of the Proximal Tibiofibular Joint Surface

研究概览

简要总结

This study aims to research on the association between the inclination of the proximal tibiofibular joint surface and medial compartment knee osteoarthritis. The proximal tibiofibular joint radiographs of the participants will be taken. The angle of inclination of the proximal tibiofibular joint surface in two groups will be compared.

详细描述

The nonuniform settlement of the tibial plateau has been introduced to explain the development of knee varus and medial compartment knee osteoarthritis. It is believed that the lateral support of the fibula to the tibial plateau leads to the nonuniform settlement and degeneration of the plateau bilaterally.

Bone mass decreases as part of the normal aging process. Varying degrees of settlement of bone mass exist in the load-bearing joints, such as the knees, hips, ankles, and spine. In the proximal tibia, the lateral support of the fibula to the lateral tibial plateau routinely leads to nonuniform settlement, which is more severe in the medial plateau than in the lateral plateau. The slope of the tibial plateau arising from nonuniform settlement results in a transverse shearing force, with the femoral condyle shifting medially during walking and sports. Furthermore, side-slip aggravates the nonuniform settlement of the tibial plateau, especially in the medial plateau. Accordingly, a cycle of increasing the load distribution in the medial compartment and nonuniform settlement occurs. This results in the load from the normal distribution shifting farther medially to the medial plateau and consequently leads to knee varus, aggravating the progression of medial compartment knee osteoarthritis.

However, the angle of inclination of the proximal tibiofibular joint surface in different individuals varied widely. The angle of inclination of the proximal tibiofibular joint may affect the nonuniform settlement of the bilateral tibial plateau.

This study aims to research on the association between the inclination of the proximal tibiofibular joint surface and medial compartment knee osteoarthritis. A sample size power analysis was conducted before the study, which revealed that a minimum of 39 subjects per group was needed to achieve statistical significance with two-sided α=0.05 and 1-ß=0.80 and an assumed mean differences between two groups = 65% of the standard deviation.

Participants will be recruited from the outpatient clinic of No.113 Hospital of Chinese People's Liberation Army, as well as advertising flyers within the clinic. Firstly, patients of the study group will be recruited. It is hoped that the number of males will be equal to the number of females. Then the controls will be recruited and matched for age (within 5 years) and sex to the cases.

研究设计

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

入排标准

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

入选标准

  • symptomatic knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint,
  • predominance of self-reported pain over the medial aspect of the knee,
  • radiographic evidence of medial compartment knee osteoarthritis with an Ahlbäck score of grade I or greater,
  • and radiographic evidence of lateral compartment with Ahlbäck classification grade 0.

排除标准

  • any previous surgery or severe trauma in the affected limb.
  • inflammatory joint disease or tumors in the affected limb.

结局指标

主要结局

The Tibial Inclination Angle of the Proximal Tibiofibular Joint Surface

时间窗: 1 day

The tibial inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula

The Fibular Inclination Angle of the Proximal Tibiofibular Joint Surface

时间窗: 1 day

The fibular inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula

次要结局

  • The Tibial PTFJ Types(1 day)
  • The Femorotibial Angle(1 day)
  • Grade of the Proximal Tibiofibular Joint Degeneration(1 day)
  • The Fibular PTFJ Types(1 day)

研究者

发起方
113th Hospital of Chinese People's Liberation Army
申办方类型
Other
责任方
Sponsor

研究点 (1)

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