Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632639
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Effect of Lateral Wedged Insoles With Subtalar Strapping on Genu Varum With Medial Compartment Knee Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Lateral Wedged Insoles With Subtalar Strapping on Genu Varum With Medial Compartment Knee Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
1 Space between knees measured by vernier calipers
2 Degree of genu varum deformity Femorotibial angle FTA measured on long film weight bearing x-ray
3 Pain level Measured by VAS
4 Hind foot angle measured by long axial hindfoot alignment view
5 Functional outcome measured by the lower extremity function scale
6 Functional performance measured by the 6 minute walk test
1 Space between knees measured by vernier calipers
2 Degree of genu varum deformity Femorotibial angle FTA measured on long film weight bearing x-ray
3 Pain level Measured by VAS
4 Hind foot angle measured by long axial hindfoot alignment view
5 Functional outcome measured by the lower extremity function scale
6 Functional performance measured by the 6 minute walk test
Detailed Description:
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 131 of all childrens 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 009 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 500000 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 patients 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
Exercises of correcting genu varum might have positive effects on changes in hip joint angle Q angle and knee space distance and lower limb deformity not by structural causes but by muscular imbalance might be corrected via consistent exercises
The results of this study could potentially inform the treatment approach for individuals with medial compartment knee pain caused by genu varum Also provides a non-invasive and cost-effective alternative to managing knee pain which can improve the quality of life for individuals suffering from this condition Additionally this study adds to the body of knowledge on the effectiveness of corrective orthoses in managing musculoskeletal disorders
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 131 of all childrens 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 009 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 500000 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 patients 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
Exercises of correcting genu varum might have positive effects on changes in hip joint angle Q angle and knee space distance and lower limb deformity not by structural causes but by muscular imbalance might be corrected via consistent exercises
The results of this study could potentially inform the treatment approach for individuals with medial compartment knee pain caused by genu varum Also provides a non-invasive and cost-effective alternative to managing knee pain which can improve the quality of life for individuals suffering from this condition Additionally this study adds to the body of knowledge on the effectiveness of corrective orthoses in managing musculoskeletal disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None