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

NCT03843684 | Completed

• 1 other identifier: 108DN07
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Medial Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Muscle co-activation ratio during level walking and stair negotiation

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

  10 minutes

Secondary Outcomes (3)

• Knee flexion moment during level walking and stair negotiation

  10 minutes

• Path of center of pressure during level walking and stair negotiation

  10 minutes

• Lower limbs joint angles during level walking and stair negotiation

  10 minutes

Study Arms (1)

Knee osteoarthritis patients

EXPERIMENTAL

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

Interventions

3D-printed foot orthoses DEVICE

3D printed foot orthoses with arch support

Knee osteoarthritis patients

5 degrees lateral wedge insoles DEVICE

Insoles with a lateral inclination set at 5 degrees

Knee osteoarthritis patients

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead
• Far Eastern Memorial Hospital: collaborator

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

Location

Study Officials

• Li-Wei Chou, PhD

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: February 18, 2019
• Study Start: April 20, 2019
• Primary Completion: November 26, 2019
• Study Completion: December 10, 2019
• Last Updated: January 13, 2020

Record last verified: 2019-02

Locations

TW (1)