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

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ClinicalTrials.gov Identifier: NCT03843684
Recruitment Status : Completed
First Posted : February 18, 2019
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Far Eastern Memorial Hospital
Information provided by (Responsible Party):
National Yang Ming University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Medial Knee Osteoarthritis Device: 3D-printed foot orthoses Device: 5 degrees lateral wedge insoles Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of 3D-printed Insoles on Lower Extremity Biomechanics and Knee Joint Loading During Walking and Stair Climbing in Individuals With Knee Osteoarthritis
Actual Study Start Date : April 20, 2019
Actual Primary Completion Date : November 26, 2019
Actual Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843684


Locations
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Taiwan
National Yang-Ming University
Taipei, Taiwan, 112
Sponsors and Collaborators
National Yang Ming University
Far Eastern Memorial Hospital
Investigators
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Principal Investigator: Li-Wei Chou, PhD National Yang Ming University
More Information
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Responsible Party: National Yang Ming University
ClinicalTrials.gov Identifier: NCT03843684    
Other Study ID Numbers: 108DN07
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases