Osteoarthritis, Knee Clinical Trial
Official title:
A 3D Printed Knee Brace to Improve Symptoms, Biomechanics and Daily Life Among Medial Knee Osteoarthritis Patients
Around 250 millions of people in the world (3.8%) have knee osteoarthritis (KOA). Due to
aging and increasing obesity, the prevalence of KOA is expected to increase in the developed
country in the next 20 years. KOA decreases quality of life of patients through chronic
pain, joint stiffness, and reduced social activity, which influence emotional wellness as
well. KOA has also impact on the biomechanics of the lower limbs, leading or amplifying the
tibiofemoral misalignment and an increase of the medial knee joint loading. Increase of the
medial knee joint loading may lead patients into a vicious circle by increasing knee pain,
decreasing activities, increasing weight and disease progression. Knee brace is a
non-pharmacological treatment recommended for KOA. It aims to reduce misalignment of the
limb. However, the main issue is the poor compliance because of lack of effectiveness, more
drawbacks than benefits, discomfort, bad fitting, migration of the brace, bulkiness,
aesthetic, skin irritation, blisters and too much pressure on the knee. By its freedom in
design, 3D printing may resolve most of these complaints.
This study aims to compare clinical and biomechanical effectiveness, comfort and patients
complaints of a knee brace made by 3D printing to a conventional knee brace.
The institute for Applied Health Research of Glasgow Caledonian University (GCU) will lead
the experimental trial. They will recruit men or women (40 to 70 years old) suffering from
medial KOA in Glasgow area. Participants will be in study for 10 weeks. During this period,
they will wear 2 different knee braces for two weeks each with a 1-week period without knee
brace between. Participants will have five visits to GCU: once for leg measurement to make
knee braces and four times to fill questionnaires and perform gait analysis. Besides, they
will wear activity monitor for 3 non-consecutive weeks.
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