Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

Does it Exist a Relationship Between Inclination Angle of Foot Orthoses and Varus Angle of the Knee in the Relief of the Knee Osteoarthritis Symptoms?

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01909596

Enrollment

Registered

2013-07-26

Start date

2011-05-31

Completion date

2012-05-31

Last updated

2024-05-16

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

Conditions

Medial Knee Osteoarthritis

Brief summary

The purpose of this is to test lateral foot orthoses with different amount of wedging to find a model that predicts the optimal lateral inclination of foot orthosis based on biomechanical or feelings measures. This study was a cross-sectional study with patients serving as their own control. The investigators recruited 24 knee osteoarthritis. Knee radiography and clinical angles measures was carried out before making orthoses, then motion analysis with an optoelectronic system was performed with each pair of foot orthoses. During motion analysis, five gait trials were carried out in each condition.

Interventions

DEVICENeutral customized foot orthoses

Foot orthoses with arch support and without lateral inclination

DEVICE6° lateral customized foot orthoses

Foot orthoses with arch support above insoles with lateral inclination set at 6°

DEVICE10° lateral customized foot orthoses

Foot orthoses with arch support above insoles with lateral inclination set at 10°

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Symptomatic medial knee osteoarthritis (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

Measure	Time frame	Description
Knee pain	At time of device receipt	A 20-cm visual analog scale (0-100) is used to assess pain.
Knee adduction moment	At time of device receipt	Measure of the knee adduction moment is a non invasive technic to identify change in medial knee loading, major problem in medial knee osteoarthritis.

Secondary

Measure	Time frame	Description
Foot orthoses comfort	At time of device receipt	A 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