Novel 3D Printed Knee Brace for Medial Knee Osteoarthritis
A 3D Printed Knee Brace to Improve Symptoms, Biomechanics and Daily Life Among Medial Knee Osteoarthritis Patients
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2016
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedMarch 3, 2017
January 1, 2017
2 months
July 27, 2016
March 1, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (14)
Change in knee brace comfort
Baseline and at 2 weeks
Change in stability feelings
Baseline and at 2 weeks
Change in Symptoms
Baseline and at 2 weeks
Change in quality of life
Baseline and at 2 weeks
Change in physical activities: Daily distance estimate
Second week of intervention
- +9 more secondary outcomes
Study Arms (2)
KNEEMO knee brace & Popular knee brace
EXPERIMENTALPatients having medial knee osteoarthritis
Popular knee brace &KNEEMO knee brace
EXPERIMENTALPatients having medial knee osteoarthritis
Interventions
Bespoke knee brace made by additive manufacturing
Customized knee brace used in the management of medial knee ostearthritis
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peacocks Medical Grouplead
- Glasgow Caledonian Universitycollaborator
- Universität Münstercollaborator
Study Sites (1)
Glasgow Caledonian University
Glasgow, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoann Dessery, PhD
Peacocks Medical Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2016
First Posted
August 19, 2016
Study Start
March 1, 2017
Primary Completion
May 1, 2017
Study Completion
June 1, 2017
Last Updated
March 3, 2017
Record last verified: 2017-01