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

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

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.

Study Overview

• Status: Completed
• Conditions: Medial Knee Osteoarthritis
• Intervention / Treatment: Device: 3D-printed foot orthoses; Device: 5 degrees lateral wedge insoles

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • National Yang-Ming University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Collaborators: Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2019
• Primary Completion (Actual): November 26, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 108DN07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No