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

NCT ID: NCT03843684

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-20
• Study Completion Date: 2019-12-10

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.

Conditions

Medial Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Knee osteoarthritis patients

Group Type: EXPERIMENTAL

3D-printed foot orthoses

Intervention Type: DEVICE

3D printed foot orthoses with arch support

5 degrees lateral wedge insoles

Intervention Type: DEVICE

Insoles with a lateral inclination set at 5 degrees

Interventions

3D-printed foot orthoses

3D printed foot orthoses with arch support

Intervention Type: DEVICE

5 degrees lateral wedge insoles

Insoles with a lateral inclination set at 5 degrees

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: collaborator

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li-Wei Chou, PhD

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University

Locations

National Yang-Ming University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

108DN07

Identifier Type: -

Identifier Source: org_study_id