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Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis

Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Medial Knee Osteoarthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01870336
Enrollment
22
Registered
2013-06-06
Start date
2012-09-30
Completion date
2014-05-31
Last updated
2016-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Brief summary

The purpose of this study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They have to wear each of treatments (foot orthoses, knee brace and combination) during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study Short Form-36( MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without treatment and ten with the treatment.

Interventions

DEVICECombined treatment of medial knee osteoarthritis

Sponsors

Natural Sciences and Engineering Research Council, Canada
CollaboratorOTHER
Fonds de la Recherche en Santé du Québec
CollaboratorOTHER_GOV
Ergorecherche Inc.
CollaboratorINDUSTRY
Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Symptomatic medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology * Knee pain \> 31/100 (Western Ontario and McMaster Universities Arthritis Index - WOMAC) * Moderately active * Varus knee alignment equal or superior to 2°

Exclusion criteria

* Severe knee OA (K-L grade IV) * Rheumatoid arthritis or other inflammatory arthritis * Avascular necrosis * History of periarticular fracture or septic arthritis * Bone metabolic disease * Pigmented villonodular synovitis * Cartilaginous disease * Neuropathic arthropathy * Synovial osteochondromatosis * Total or partial knee arthroplasty * Flexion contracture of ipsi- or contra-lateral knee greater than 15° * Hip or ankle joint damage with mobility limitation * Obesity (BMI ≥ 40) * Intra-articular corticosteroids injection in the affected knee during the two previous months * Reduced mobility (Charnley class C)

Design outcomes

Primary

MeasureTime frameDescription
Change in Knee adduction momentChange from Baseline at 3 months
Change in Knee painChange from Baseline at 3 monthsA 20-cm visual analog scale (0-100) is used to assess pain.

Secondary

MeasureTime frameDescription
Change in Spatiotemporal gait parametersChange from Baseline at 3 months
Change in Knee adduction angleChange from Baseline at 3 months
Change in ComfortChange from Baseline at 3 monthsA 20-cm visual analog scale (0-100) is used to assess comfort.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026