Skip to main content
OpenTrials
Completed

NCT Number: NCT03843684

Effects of 3D-printed on Lower Extremity Biomechanics 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Medial Knee Osteoarthritis

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D-printed foot orthoses

Device

3D printed foot orthoses with arch support

5 degrees lateral wedge insoles

Device

Insoles with a lateral inclination set at 5 degrees

Primary outcomes

  1. Knee adduction moment during level walking and stair negotiation

    Time frame: 10 minutes

    Surrogate marker of medial knee loading. Using motion capture system data to calculate the knee adduction moment via inverse dynamics method.

  2. Medial knee joint contact force during level walking and stair negotiation

    Time frame: 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.

  3. Muscle co-activation ratio during level walking and stair negotiation

    Time frame: 10 minutes

    Level of muscle co-activation measured by electromyography (EMG).

Secondary outcomes

  1. Knee flexion moment during level walking and stair negotiation

    Time frame: 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).

  2. Path of center of pressure during level walking and stair negotiation

    Time frame: 10 minutes

    The factor of affect the joint moments. Measured by force platform.

  3. Lower limbs joint angles during level walking and stair negotiation

    Time frame: 10 minutes

    Lower limbs alignment, including hip, knee and ankle joints. Using motion capture system data to calculate the joint angles.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Collaborators

  • Far Eastern Memorial Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 18, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.