Effect of Lateral Wedged Insoles With Subtalar Strapping on Genu Varum With Medial Compartment Knee Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Distance between knees using vernier calipers
研究概览
简要总结
The purpose of the study is to investigate the effect of lateral wedged insoles with subtalar strapping in genu varum with medial compartment knee pain on:
- Space between knees (measured by vernier calipers)
- Degree of genu varum deformity (Femorotibial angle (FTA)) measured on long film weight bearing x-ray)
- Pain level (Measured by VAS)
- Hind foot angle (measured by long axial hindfoot alignment view)
- Functional outcome (measured by the lower extremity function scale)
- Functional performance (measured by the 6 minute walk test)
详细描述
Genu varum is known as one of the most common lower limb abnormalities. Genu varum is reported to occur 15 to 20% in the whole population. In most cases, this deformity occurs between tillage damage and degeneration in the medial compartment of the knee joint in the long term, because of the imposed imbalanced force on medial and lateral compartments of knees.
Incidence of rachitic genu varum in preschool children: A more recent study from 2016 estimated the incidence of vitamin D deficient rachitic genu varum among preschool children in Egypt, finding it to be 13.1% of all children's orthopaedic diseases at the National Institute of Neuromotor System.
Prevalence of lower limb deformities in primary school students: A 2021 study reported a much lower prevalence of genu varum (0.09%) among primary school students in Egypt. This suggests that the condition may be more prevalent in younger children and decrease in severity with age.
Surgical treatments, such as high tibial osteotomy and total knee arthroplasty (TKA) have been performed. Although this type of surgery has provided successful clinical results, it is often costly for the patients and it forces them to get over complications. In particular, more than 500,000 cases of TKA are annually performed in the US, and approximately three billion dollars are spent on TKA. Alternatives to surgical treatment are required to lighten the patient's burden and the medical costs.
lateral wedged insole significantly reduces the knee varus moment during walking compared to the barefoot condition with no insole. In particular, the strapping insole reduces the varus moment more than the lateral wedged insole alone in moderate OA.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders aged 20-
- •Patients with medial compartment pain. Pain level of 3 or more on the VAS.
- •Patients with varus deformity are defined as those Those whose femorotibial angle measures 5-10 degrees of genu varum on long film weight bearing x-ray.
- •Patients with grade one O.A. on Kellgren-Lawrence classification system or without O.A.
- •BMI less than 35
- •Patients with decompensated hind foot (hind foot varus)
排除标准
- •Patients already wearing custom wedged insoles.
- •Patients with other inflammatory conditions like rheumatoid arthritis or systematic inflammatory arthritis.
- •Patients with central or peripheral nervous system disease.
- •Any previous surgical procedure to the knee joint.
- •Patients who are unable to walk without assistance (cane or a walker).
- •Pregnancy
- •Uncooperative patient types due to mental disorders or others.
结局指标
主要结局
Distance between knees using vernier calipers
时间窗: 12 weeks
To measure the distance between the participants' knees, we have them put both feet together, so that both malleolus bones were together, and measured the space between the tibia and medial condyle using vernier calipers.
次要结局
- Degree of genu varum deformity measured by long film weight bearing X-Ray(12 weeks)
- Pain level measured by the visual analogue scale (VAS)(12 weeks)
- Hind foot angle measured by long axial hindfoot alignment view(12 weeks)
- Functional outcome measured by lower extremity function scale (LEFS)(12 weeks)
- Functional performance measured by the 6 minute walk test(12 weeks)
研究者
Ali Abdelmoniem Ali Hassanien
Principal Investigator
Cairo University
