A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis

NARecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 4, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Knee Osteoarthritis
Interventions
DEVICE

Lateral wedge insoles (LWIs)

Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. The LWIs will be constructed via 3D printing using a material of uniform density made to the length of the participant's feet, and will incorporate a 6 degree wedge along the lateral edge.

DEVICE

Lateral wedge plus custom arch support (LWAS)

Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. These insoles will be designed based on an innovative tablet-based app designed by industry partner Kintec Footlabs, who will be the provider of the insoles for this project. Using the high-fidelity 3D scanning tool available (Apple's True Depth sensor), the Epitek Self-Scanner app captures tens of thousands of 3D data points within a single 1-second capture, and then uploads this foot data to a secure patient record system that is used for insole fabrication. The LWAS insoles will be comprised of variable density material (more dense laterally than medially) and milled directly to produce a full-length shell. The 6 degree wedge will be incorporated along the full lateral length of the insoles.

Trial Locations (1)

V5R 3N9

RECRUITING

Motion Analysis and Biofeedback Laboratory, Vancouver

All Listed Sponsors
collaborator

Western University

OTHER

collaborator

Dalhousie University

OTHER

lead

University of British Columbia

OTHER