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CompletedNCT03843684Updated Jan 13, 2020

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

An interventional study of 3D-printed foot orthoses and 5 degrees lateral wedge insoles in Medial Knee Osteoarthritis, sponsored by National Yang Ming Chiao Tung University. Completed at 1 site in Taiwan. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
50 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Medial Knee Osteoarthritis
03

In context

Osteoarthritis

4,397 studies on the registry are indexed under Osteoarthritis; 581 are open to participants now.

This study's enrollment of 15 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Knee osteoarthritis patients

    Device: 3D-printed foot orthoses · Device: 5 degrees lateral wedge insoles

Interventions

  • Device3D-printed foot orthoses

    3D printed foot orthoses with arch support

  • Device5 degrees lateral wedge insoles

    Insoles with a lateral inclination set at 5 degrees

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 minutes

  2. 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.

    Time frame: 10 minutes

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

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

    Time frame: 10 minutes

Secondary outcomes

  1. 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).

    Time frame: 10 minutes

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

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

    Time frame: 10 minutes

  3. 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.

    Time frame: 10 minutes

07

Study locations

1 site
  • National Yang-Ming University
    Taipei, 112, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03843684
Lead sponsor
National Yang Ming Chiao Tung University
Collaborators
Far Eastern Memorial Hospital
Responsible party
Sponsor
First posted
Feb 18, 2019
Start date
Apr 20, 2019
Primary completion
Nov 26, 2019
Completion
Dec 10, 2019
Last update
Jan 13, 2020

Study contacts

Li-Wei Chou, PhD
principal investigator · National Yang Ming Chiao Tung University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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