Effects of 3D-printed on Lower Extremity Biomechanics in Individuals With Knee Osteoarthritis

Study Overview
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Brief Summary
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The purposes of this study are: (1) to determine the kinematics, kinetics, and muscle co-activation ratio of level walking and stair negotiation under three different conditions (shoes only, shoes embedded 3D printed insoles, and shoes embedded 5-degree lateral wedges), (2) to build a detailed patient-specific knee model via MR images and musculoskeletal model, then, evaluate the compressive forces acting on the medial aspect of the knee during level walking and stair negotiation.

Detailed Description
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This study is a cross-sectional study with patients serving as their own control. The investigators will recruit 20 patients with knee osteoarthritis. Using motion capture system, force plates, wireless EMG to capture the motion data of patients during walking and stair negotiation in each condition.

Official Title
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Effects of 3D-printed Insoles on Lower Extremity Biomechanics and Knee Joint Loading During Walking and Stair Climbing in Individuals With Knee Osteoarthritis

Conditions
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Medial Knee Osteoarthritis

Intervention / Treatment
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* Device: 3D-printed foot orthoses
* Device: 5 degrees lateral wedge insoles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology Aged from 50 to 70 years Exclusion Criteria: Neuromuscular illness (e.g., Parkinson disease, Neuropathy) Predominant lateral or patella-femoral OA Previous of planned hip or knee replacement Hip or ankle arthritis Rheumatoid arthritis Unable to walk without a cane or walker Unable to walk up and down the stairs

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Knee osteoarthritis patients<br> | Device: 3D-printed foot orthoses<br>* 3D printed foot orthoses with arch support<br>Device: 5 degrees lateral wedge insoles<br>* Insoles with a lateral inclination set at 5 degrees<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee adduction moment during level walking and stair negotiation | Surrogate marker of medial knee loading. Using motion capture system data to calculate the knee adduction moment via inverse dynamics method. | 10 minutes | 
| Medial knee joint contact force during level walking and stair negotiation | Calculate the medial knee force to identify the change in medial knee loading by musculoskeletal model. The musculoskeletal model is driven by motion capture system data. | 10 minutes | 
| Muscle co-activation ratio during level walking and stair negotiation | Level of muscle co-activation measured by electromyography (EMG). | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee flexion moment during level walking and stair negotiation | Surrogate marker of medial and lateral knee loading. Using motion capture system data to calculate the joint moments via inverse dynamics method. The calculated joint moments (N*m) will be normalized by multiplying body weight (Newton) and leg length (meter). | 10 minutes | 
| Path of center of pressure during level walking and stair negotiation | The factor of affect the joint moments. Measured by force platform. | 10 minutes | 
| Lower limbs joint angles during level walking and stair negotiation | Lower limbs alignment, including hip, knee and ankle joints. Using motion capture system data to calculate the joint angles. | 10 minutes |