Clinical trial NCT02873403: Novel 3D Printed Knee Brace for Medial Knee Osteoarthritis
Official title: A 3D Printed Knee Brace to Improve Symptoms, Biomechanics and Daily Life Among Medial Knee Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Peacocks Medical Group
Sponsor class: INDUSTRY
Collaborators: name: Glasgow Caledonian University
name: Universität Münster
First posted: 2016-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in knee pain during gait and stairs ambulation
timeFrame: Baseline and at 2 weeks
measure: Change in knee adduction moment during gait and stairs ambulation
timeFrame: Baseline and at 2 weeks
Secondary outcomes:
measure: Change in knee brace comfort
timeFrame: Baseline and at 2 weeks
measure: Change in stability feelings
timeFrame: Baseline and at 2 weeks
measure: Change in Symptoms
timeFrame: Baseline and at 2 weeks
measure: Change in quality of life
timeFrame: Baseline and at 2 weeks
measure: Change in physical activities: Daily distance estimate
timeFrame: Second week of intervention
measure: Change in physical activities: Daily duration of sitting/standing/stair climbing
timeFrame: Second week of intervention
measure: Change in physical activities: Daily number of sitting/standing/stair climbing
timeFrame: Second week of intervention
measure: Change in physical activities: Weekly number of activities with moderate and high intensity
timeFrame: Second week of intervention
measure: Change in physical activities: Weekly duration of activities with moderate and high intensity
timeFrame: Second week of intervention
measure: Change in knee flexion moment during gait and stairs ambulation
timeFrame: Baseline and at 2 weeks
measure: Change in duration of phases of gait and stairs ambulation
timeFrame: Baseline and at 2 weeks
measure: Change in step length of gait
timeFrame: Baseline and at 2 weeks
measure: Change in knee flexion/extension range of motion during gait and stairs ambulation
timeFrame: Baseline and at 2 weeks
measure: Change in knee adduction/abduction range of motion during gait and stairs ambulation
timeFrame: Baseline and at 2 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
Study officials:
affiliation: Peacocks Medical Group
name: Yoann Dessery, PhD
role: PRINCIPAL_INVESTIGATOR
References: