A novel additive manufacturing knee brace to improve symptoms, biomechanics and daily life in medial knee osteoarthritis: a crossover randomized controlled trial

Peacocks Medical Group Ltd (UK)0 sites10 target enrollmentAugust 16, 2016

Overview

No summary available.

Registry

who.int

Start Date

August 16, 2016

End Date

June 30, 2017

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Peacocks Medical Group Ltd (UK)

•1\. Male or female aged between 40 and 70 years old having radiological and symptomatic medial knee osteoarthritis (Kellgren\-Lawrence grade II, III or IV) according to the American College of Rheumatology’s clinical and radiological criteria (Altman, 1986\)
•2\. Average knee pain \> 4/10 (VAS score assessed three times in two weeks before being included)
•3\. Not currently wearing knee brace
•4\. Varus knee alignment equal or superior to 2°
•5\. No or light pain from the hips, ankles, feet or lumbar spine
•6\. Moderately physically active
•7\. Able to understand written and spoken English

•1\. Mild knee osteoarthritis (Kellgren\-Lawrence grade I)
•2\. Lateral or patellar knee osteoarthritis
•3\. Chronic diseases or conditions (e.g., diabetes, osteoporosis, heart disease, hypertension, neurological disorders)
•4\. Stroke history
•5\. Inflammatory arthritis (gout, rheumatoid arthritis, psoriatic arthritis etc)
•6\. Musculoskeletal disorders that could influence their ability to stand and walk
•7\. Morbid obesity (BMI \> 35\)
•8\. Intra\-articular corticosteroid/hyaluronan injection in the affected knee in the past 3 months
•9\. Unstable medication schedule and medication that causes dizziness
•10\. Severe recent modification of diet