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

Primary Purpose

Medial Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
3D-printed foot orthoses
5 degrees lateral wedge insoles
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medial Knee Osteoarthritis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Yang-Ming University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Knee osteoarthritis patients

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
Muscle co-activation ratio during level walking and stair negotiation
Level of muscle co-activation measured by electromyography (EMG).

Secondary Outcome Measures

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).
Path of center of pressure during level walking and stair negotiation
The factor of affect the joint moments. Measured by force platform.
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.

Full Information

First Posted
December 12, 2018
Last Updated
January 9, 2020
Sponsor
National Yang Ming University
Collaborators
Far Eastern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03843684
Brief Title
Effects of 3D-printed on Lower Extremity Biomechanics in Individuals With Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
Collaborators
Far Eastern Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Knee osteoarthritis patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
3D-printed foot orthoses
Intervention Description
3D printed foot orthoses with arch support
Intervention Type
Device
Intervention Name(s)
5 degrees lateral wedge insoles
Intervention Description
Insoles with a lateral inclination set at 5 degrees
Primary Outcome Measure Information:
Title
Knee adduction moment during level walking and stair negotiation
Description
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
Title
Medial knee joint contact force during level walking and stair negotiation
Description
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
Title
Muscle co-activation ratio during level walking and stair negotiation
Description
Level of muscle co-activation measured by electromyography (EMG).
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Knee flexion moment during level walking and stair negotiation
Description
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
Title
Path of center of pressure during level walking and stair negotiation
Description
The factor of affect the joint moments. Measured by force platform.
Time Frame
10 minutes
Title
Lower limbs joint angles during level walking and stair negotiation
Description
Lower limbs alignment, including hip, knee and ankle joints. Using motion capture system data to calculate the joint angles.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Wei Chou, PhD
Organizational Affiliation
National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

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

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