Novel 3D Printed Knee Brace for Medial Knee Osteoarthritis

Summary

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.

Conditions

• Osteoarthritis, Knee

Interventions

DEVICE

KNEEMO knee brace

Bespoke knee brace made by additive manufacturing

DEVICE

Popular knee brace

Customized knee brace used in the management of medial knee ostearthritis

Sponsors & Collaborators

• Glasgow Caledonian University

  collaborator OTHER

• Universität Münster

  collaborator OTHER

• Peacocks Medical Group

  lead INDUSTRY

Principal Investigators

• Yoann Dessery, PhD · Peacocks Medical Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-31

Primary Completion

2017-05-31

Completion

2017-06-30

Countries

• United Kingdom

Study Locations