Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis

Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis on the Medial Knee Loading During Gait

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01866176

Enrollment

Registered

2013-05-31

Start date

2011-10-31

Completion date

2013-08-31

Last updated

2014-03-06

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

Conditions

Knee Osteoarthritis

Brief summary

The purpose of this study is to evaluate the immediate effects of a knee brace with a new mechanism on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of this new brace is compared to a stabilizing brace and a typical valgus knee brace. The investigators recruited 24 knee osteoarthritis and they have to wear each of the three braces 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 (KOOS, WOMAC and Medical Outcome Score 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 brace and ten with the brace.

Interventions

DEVICEStabilizing Knee Brace

Brace with no valgus action

DEVICEValgus Knee Brace

Valgus brace with traditional three point bending system

DEVICENew Knee Brace

Brace with new mechanism to decrease the knee loading.

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

Yes

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

Measure	Time frame	Description
Change in Knee adduction moment	Change from Baseline at 3 months	—
Change in Knee pain	Change from Baseline at 3 months	A 20-cm visual analog scale (0-100) is used to assess pain.

Secondary

Measure	Time frame	Description
Change in Knee brace comfort	Change from Baseline at 3 months	A 20-cm visual analog scale (0-100) is used to assess comfort.
Change in Spatiotemporal gait parameters	Change from Baseline at 3 months	Test of the gait symmetry with the gait phase duration and step length.
Change in Gait velocity	Change from Baseline at 3 months	—
Change in Knee adduction angle	Change from Baseline at 3 months	—

Countries

Canada

Outcome results

None listed

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