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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03843684

Enrollment

Registered

2019-02-18

Start date

2019-04-20

Completion date

2019-12-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medial Knee Osteoarthritis

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.

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Knee adduction moment during level walking and stair negotiation	10 minutes	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	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.
Muscle co-activation ratio during level walking and stair negotiation	10 minutes	Level of muscle co-activation measured by electromyography (EMG).

Secondary

Measure	Time frame	Description
Knee flexion moment during level walking and stair negotiation	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).
Path of center of pressure during level walking and stair negotiation	10 minutes	The factor of affect the joint moments. Measured by force platform.
Lower limbs joint angles during level walking and stair negotiation	10 minutes	Lower limbs alignment, including hip, knee and ankle joints. Using motion capture system data to calculate the joint angles.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026