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Comparison of Different Insoles as Conservative Treatment for Medial Knee Osteoarthritis

NCT04967339 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-02-10

No results posted yet for this study

Summary

In patients with early to mid-stage knee osteoarthritis (OA), a conservative treatment is indicated. In medial knee OA (when mainly the medial compartment of the knee is affected by OA), lateral wedge insoles have been promoted as cost effective and simple solution. However, clinical trials report conflicting results, with some reporting no benefit while others reported a small decrease in knee pain. Recent studies reported medial OA patients to have a tendency to a plano-valgus foot deformity, which is associated with a varus lower limb alignment and an internal rotation of the tibia. Some authors thus proposed the correction of plano-valgus deformity with foot deformity correcting insoles instead of lateral wedge insoles. Until today, only one study investigated the effect of foot deformity correcting insoles (e.g. with medial arch support) as alternative to lateral wedge insoles and reported encouraging results. However, they used lateral wedge insoles with custom arch support instead of foot deformity correcting customized insoles along (without lateral wedge). Furthermore, they did not perform any biomechanical analyses. The primary object of this study is to compare the effect of foot deformity correcting insoles for plano-valgus foot deformities and lateral wedge insoles on knee load distribution, knee pain and patient reported outcome measures in early to mid-stage medial knee OA patients after 6 and 12 months.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Foot deformity correcting insoles

Foot deformity correcting insoles (e.g. insoles with medial arch support for plano-valgus deformity)

DEVICE

Lateral wedge insoles

Lateral wedge insoles

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Frank Klenke, Prof · Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-08-01
Completion
2023-08-01

Countries

  • Switzerland

Study Locations

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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 NCT04967339 on ClinicalTrials.gov