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

Medial Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843684
• Other study ID #: 108DN07
• Status: Completed
• Phase: N/A
• Start date: April 20, 2019
• Est. completion date: December 10, 2019

Study information

• Verified date: February 2019
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 10, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Medial Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• 3D-printed foot orthoses
3D printed foot orthoses with arch support
• 5 degrees lateral wedge insoles
Insoles with a lateral inclination set at 5 degrees

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Muscle co-activation ratio during level walking and stair negotiation	Level of muscle co-activation measured by electromyography (EMG).	10 minutes
Secondary	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
Secondary	Path of center of pressure during level walking and stair negotiation	The factor of affect the joint moments. Measured by force platform.	10 minutes
Secondary	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