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

Not Applicable

Completed

• Conditions: Medial Knee Osteoarthritis
• Interventions: Device: 3D-printed foot orthoses; Device: 5 degrees lateral wedge insoles

• Registration Number: NCT03843684
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-12-12
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-18
• Study Start: 2019-04-20
• Primary Completion: 2019-11-26
• Study Completion: 2019-12-10
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Knee osteoarthritis patients	5 degrees lateral wedge insoles	-
Knee osteoarthritis patients	3D-printed foot orthoses	-

Primary Outcome Measures

Name	Time	Method
Knee adduction moment during level walking and stair negotiation	10 minutes	Surrogate marker of medial knee loading. Using motion capture system data to calculate the knee adduction moment via inverse dynamics method.
Muscle co-activation ratio during level walking and stair negotiation	10 minutes	Level of muscle co-activation measured by electromyography (EMG).
Medial knee joint contact force during level walking and stair negotiation	10 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Knee flexion moment during level walking and stair negotiation	10 minutes	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).
Path of center of pressure during level walking and stair negotiation	10 minutes	The factor of affect the joint moments. Measured by force platform.
Lower limbs joint angles during level walking and stair negotiation	10 minutes	Lower limbs alignment, including hip, knee and ankle joints. Using motion capture system data to calculate the joint angles.

Trial Locations

Locations (1)

National Yang-Ming University; 🇨🇳 Taipei, Taiwan