Osteoarthritis, KneeNCT02873403
Novel 3D Printed Knee Brace for Medial Knee Osteoarthritis
A study testing KNEEMO knee brace and Popular knee brace in people with Osteoarthritis, Knee, run by Peacocks Medical Group at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- KNEEMO knee brace and Popular knee brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2017to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Yoann Dessery, PhD contact
Jari Pallari, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Glasgow Caledonian University
Glasgow
Yoann Dessery, PhD, yoann.dessery@peacocks.net
Yoann Dessery, PhD
About this study
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- KNEEMO knee brace, Popular knee brace
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KNEEMO knee braceDevice
Bespoke knee brace made by additive manufacturing
Popular knee braceDevice
Customized knee brace used in the management of medial knee ostearthritis
| Study group | Role | What they receive |
|---|---|---|
| KNEEMO knee brace & Popular knee brace | Experimental | Patients having medial knee osteoarthritis Receives: Device: KNEEMO knee brace; Device: Popular knee brace |
| Popular knee brace &KNEEMO knee brace | Experimental | Patients having medial knee osteoarthritis Receives: Device: KNEEMO knee brace; Device: Popular knee brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee pain during gait and stairs ambulation
Measured with 10-cm visual analog scale
Measured: 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.
Measured: Baseline and at 2 weeks
Secondary outcomes (14)
Change in knee brace comfort
Measured with 10-cm visual analog scale
Measured: Baseline and at 2 weeks
Change in stability feelings
Measured with 10-cm visual analog scale
Measured: Baseline and at 2 weeks
Change in Symptoms
KOOS questionnaires subscales
Measured: Baseline and at 2 weeks
Change in quality of life
MOS SF-36 questionnaires subscales
Measured: Baseline and at 2 weeks
Change in physical activities: Daily distance estimate
Measured (in km) during one week with an activity monitor.
Measured: 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.
Measured: Second week of intervention
Change in physical activities: Daily number of sitting/standing/stair climbing
Measured during one week with an activity monitor.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and at 2 weeks
Change in step length of gait
Measured in meters from gait analysis data
Measured: 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
Measured: 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
Measured: Baseline and at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startMar 2017 (estimated)
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peacocks Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glasgow Caledonian University, Universität Münster
- Responsible party
- Sponsor
- Investigators
- Yoann Dessery, PhD, Principal investigator, Peacocks Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873403
- Sponsor's protocol ID
- AMKNEEBRACE01
- Status last verified
- Jan 2017
- First submitted
- 27 Jul 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3D Printed Knee Brace to Improve Symptoms, Biomechanics and Daily Life Among Medial Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT02873403
- Acronym / sponsor ID
- AMKNEEBRACE01
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peacocks Medical GroupIndustry (pharma, biotech, devices)
- Collaborators
- Glasgow Caledonian University, Universität Münster
- Study start
- Mar 2017 (estimated)
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KNEEMO knee brace & Popular knee brace | Experimental | Device: KNEEMO knee brace, Device: Popular knee bracePatients having medial knee osteoarthritis |
| Popular knee brace &KNEEMO knee brace | Experimental | Device: KNEEMO knee brace, Device: Popular knee bracePatients having medial knee osteoarthritis |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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, …)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KNEEMO knee braceBespoke knee brace made by additive manufacturing | Device | KNEEMO knee brace & Popular knee brace, Popular knee brace &KNEEMO knee brace |
| Popular knee braceCustomized knee brace used in the management of medial knee ostearthritis | Device | KNEEMO knee brace & Popular knee brace, Popular knee brace &KNEEMO knee brace |
Primary outcome
Change in knee pain during gait and stairs ambulation
Time frame: Baseline and at 2 weeks
Measured with 10-cm visual analog scale
Change in knee adduction moment during gait and stairs ambulation
Time frame: Baseline and at 2 weeks
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.
14 secondary outcomes
Change in knee brace comfort
Time frame: Baseline and at 2 weeks
Change in stability feelings
Time frame: Baseline and at 2 weeks
Change in Symptoms
Time frame: Baseline and at 2 weeks
Change in quality of life
Time frame: Baseline and at 2 weeks
Change in physical activities: Daily distance estimate
Time frame: Second week of intervention
Change in physical activities: Daily duration of sitting/standing/stair climbing
Time frame: Second week of intervention
Change in physical activities: Daily number of sitting/standing/stair climbing
Time frame: Second week of intervention
Change in physical activities: Weekly number of activities with moderate and high intensity
Time frame: Second week of intervention
Change in physical activities: Weekly duration of activities with moderate and high intensity
Time frame: Second week of intervention
Change in knee flexion moment during gait and stairs ambulation
Time frame: Baseline and at 2 weeks
Change in duration of phases of gait and stairs ambulation
Time frame: Baseline and at 2 weeks
Change in step length of gait
Time frame: Baseline and at 2 weeks
Change in knee flexion/extension range of motion during gait and stairs ambulation
Time frame: Baseline and at 2 weeks
Change in knee adduction/abduction range of motion during gait and stairs ambulation
Time frame: Baseline and at 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoann Dessery, PhD contact
Jari Pallari, PhD contact
Yoann Dessery, PhD principal investigator
Peacocks Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KNEEMO knee brace and Popular knee brace in people with Osteoarthritis, Knee, run by Peacocks Medical Group at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoann Dessery, PhD (yoann.dessery@peacocks.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee pain during gait and stairs ambulation (time frame: Baseline and at 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.