Novel 3D Printed Knee Brace for Medial Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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A 3D Printed Knee Brace to Improve Symptoms, Biomechanics and Daily Life Among Medial Knee Osteoarthritis Patients

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: KNEEMO knee brace
* Device: Popular knee brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged between 40 and 70 years old having radiological and symptomatic medial KOA (Kellgren-Lawrence grade II, III or IV) according to the American College of Rheumatology's clinical and radiological criteria [83] Average knee pain > 4/10 (VAS score assessed three times in two weeks before being included) Not currently wearing knee brace Varus knee alignment equal or superior to 2° No or light pain from the hips, ankles, feet or lumbar spine Moderately physically active Able to understand written and spoken English. Exclusion Criteria: Mild KOA (Kellgren-Lawrence grade I) Lateral or patellar KOA Chronic diseases or conditions (e.g., diabetes, osteoporosis, heart disease, hypertension, neurological disorders) Stroke history Inflammatory arthritis (gout, RA, psoriatic arthritis, …) Musculoskeletal disorders that could influence their ability to stand and walk Morbid obesity (BMI > 35) Intra-articular corticosteroid/hyaluronan injection in the affected knee in the past 3 months Unstable medication schedule and medication that causes dizziness Severe recent modification of diet Prosthetic implants in the hip, knee or ankle joint Poor skin condition Unable to walk, walk up and down stairs or any condition contraindicating the demands of the gait analysis.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KNEEMO knee brace & Popular knee brace<br>Patients having medial knee osteoarthritis | Device: KNEEMO knee brace<br>* Bespoke knee brace made by additive manufacturing<br>Device: Popular knee brace<br>* Customized knee brace used in the management of medial knee ostearthritis<br>|
| Experimental: Popular knee brace &KNEEMO knee brace<br>Patients having medial knee osteoarthritis | Device: KNEEMO knee brace<br>* Bespoke knee brace made by additive manufacturing<br>Device: Popular knee brace<br>* Customized knee brace used in the management of medial knee ostearthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knee pain during gait and stairs ambulation | Measured with 10-cm visual analog scale | Baseline and at 2 weeks | 
| Change in knee adduction moment during gait and stairs ambulation | Knee adduction moment (KAM) will be calculated from motion capture and force plate data. KAM characterizes knee loading, especially peaks and angular impulse (area under the KAM curve) to have information about maximum and total knee loading, respectively. | Baseline and at 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knee brace comfort | Measured with 10-cm visual analog scale | Baseline and at 2 weeks | 
| Change in stability feelings | Measured with 10-cm visual analog scale | Baseline and at 2 weeks | 
| Change in Symptoms | KOOS questionnaires subscales | Baseline and at 2 weeks | 
| Change in quality of life | MOS SF-36 questionnaires subscales | Baseline and at 2 weeks | 
| Change in physical activities: Daily distance estimate | Measured (in km) during one week with an activity monitor. | Second week of intervention | 
| Change in physical activities: Daily duration of sitting/standing/stair climbing | Measured in seconds during one week with an activity monitor. | Second week of intervention | 
| Change in physical activities: Daily number of sitting/standing/stair climbing | Measured during one week with an activity monitor. | Second week of intervention | 
| Change in physical activities: Weekly number of activities with moderate and high intensity | Measured during one week with an activity monitor. | Second week of intervention | 
| Change in physical activities: Weekly duration of activities with moderate and high intensity | Measured in minutes during one week with an activity monitor. | Second week of intervention | 
| Change in knee flexion moment during gait and stairs ambulation | Maximum knee flexion moment will be calculated from gait analysis data. | Baseline and at 2 weeks | 
| Change in duration of phases of gait and stairs ambulation | Measured in percentage of gait cycle from gait analysis data. | Baseline and at 2 weeks | 
| Change in step length of gait | Measured in meters from gait analysis data | Baseline and at 2 weeks | 
| Change in knee flexion/extension range of motion during gait and stairs ambulation | Measured during the gait cycle based on gait analysis data | Baseline and at 2 weeks | 
| Change in knee adduction/abduction range of motion during gait and stairs ambulation | Measured during the gait cycle based on gait analysis data | Baseline and at 2 weeks |