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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We will conduct a two-arm, parallel group, multi-centre randomized controlled pilot study to assess the feasibility of our unique clinical biomechanics study, as well as the preliminary efficacy of the interventions on clinical and biomechanical outcomes at the feet and knees.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Participants will be aware that there will be different types of insole interventions for this study, but will not be aware of the exact details of the insoles.

Given that biomechanical assessment will be conducted in the intervention insole, it is not possible to mask the outcome assessor to intervention arm for participants. Instead, an investigator not involved in data collection will process all biomechanical data without knowledge of the intervention for a given participant.

Study Groups

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Lateral wedge insoles (LWIs)

The LWIs will incorporate a 6 degree wedge along the lateral edge of the insole.

Group Type EXPERIMENTAL

Lateral wedge insoles (LWIs)

Intervention Type DEVICE

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.

Lateral wedge plus custom arch support (LWAS)

The LWAS insoles will incorporate custom arch support along the medial edge as well as a 6 degree wedge along the lateral edge of the insole.

Group Type EXPERIMENTAL

Lateral wedge plus custom arch support (LWAS)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* medial tibiofemoral OA defined as definitive osteophytes and joint space narrowing in the medial compartment, as confirmed with radiographs
* history of knee pain longer than 6 months
* average self-reported knee pain of at least 3 out of 10 (using an 11-point numerical rating scale with terminal descriptors of 0 = "no pain" and 10 = "worst pain imaginable") over the 6 months prior to baseline testing
* pain in the same foot/feet as the painful knee(s)
* ability to communicate in English
* show an immediate biomechanical response to the insoles. This final eligibility criterion will be determined from an in-person biomechanical assessment after participants have passed all previous eligibility screening.

Exclusion Criteria

* radiographic evidence of more lateral tibiofemoral OA than medial
* knee surgery or intra-articular injection within the previous 6 months
* current or recent (within 6 months) corticosteroid use for any reason
* presence of a systemic arthritic condition
* history of knee joint replacement or tibial osteotomy
* any other condition affecting lower limb function
* current usage of shoe-worn insoles, or planning to acquire footwear modifications in the next 6 months
* any previous experience with insoles that resulted in increased lower limb pain or a self- or clinician-initiated termination of use.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No