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

NCT06251167 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-03-25

No results posted yet for this study

Summary

Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.

Conditions

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.

Sponsors & Collaborators

  • Western University

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06251167 on ClinicalTrials.gov