Condition category
Musculoskeletal Diseases
Date applied
27/07/2016
Date assigned
16/08/2016
Last edited
26/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Osteoarthritis is the 'wear and tear' form of arthritis affecting the joints. Around 250 million people in the world (3.8%) have knee osteoarthritis. Due to aging and increasing obesity, the prevalence of knee osteoarthritis is expected to increase in developed countries in the next 20 years. Knee osteoarthritis decreases patients' quality of life through chronic pain, joint stiffness, and reduced social activity, which influence emotional wellness as well. Knee osteoarthritis can also lead to or increase misalignment of the thighbone and shinbone and increase the force on the knee joint, leading patients into a vicious circle by increasing knee pain, decreasing activities, increasing weight and progressing the disease. A knee brace is a brace worn to strengthen the knee and is a recommended treatment for knee osteoarthritis. It aims to reduce misalignment of the limb. However, the main issue is patients' poor compliance to the treatment because of lack of effectiveness, more drawbacks than benefits, discomfort, bad fitting, movement of the brace, bulkiness, appearance, 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 the effectiveness and comfort of a knee brace made by 3D printing and a conventional knee brace.

Who can participate?
Patients aged 40 to 70 with medial knee osteoarthritis

What does the study involve?
Participants are in the study for 10 weeks. During this period, they wear two different knee braces for two weeks each with a 1-week period without a knee brace in between. Participants attend Glasgow Caledonian University for five visits: once for leg measurement to make the knee braces and four times to fill in questionnaires and perform gait (walking) analysis. Participants also wear activity monitors for three non-consecutive weeks.

What are the possible benefits and risks of participating?
By participating in this study, participants may benefit from pain relief, symptom reduction and improvement in daily life activities. Besides, participants keep the knee brace of their choice at the end of the study. Wearing knee braces may sometimes lead to a rash, allergic skin irritations, and knee lock. However, these risks are minors and reversible.

Where is the study run from?
The Institute for Applied Health Research of Glasgow Caledonian University (UK)

When is the study starting and how long is it expected to run for?
October 2016 to March 2017

Who is funding the study?
EU Seventh Framework Programme

Who is the main contact?
Dr Yoann Dessery
yoann.dessery@peacocks.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Yoann Dessery

ORCID ID

http://orcid.org/0000-0001-5198-356X

Contact details

Peacocks Medical Group
Benfield Park Business
Benfield Road
Newcastle upon Tyne
NE64NQ
United Kingdom
+44 (0)191 276 9674
yoann.dessery@peacocks.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AMKNEEBRACE01

Study information

Scientific title

A novel additive manufacturing knee brace to improve symptoms, biomechanics and daily life in medial knee osteoarthritis: a crossover randomized controlled trial

Acronym

Study hypothesis

The new knee brace has at least equivalent clinical and biomechanical effectiveness and better comfort and compliance for patients than a conventional customized knee brace for management of the knee osteoarthritis.

Ethics approval

NHS and Glasgow Caledonian University research ethics committee - approval pending

Study design

Double-blinded crossover superiority randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Medial tibiofemoral knee osteoarthritis

Intervention

Participants will be in the study for 10 weeks. During this period, they will wear two different knee braces (Unloader One knee brace and novel knee brace) and for two weeks each with a 1-week period without knee brace between. Participants will have five visits to Glasgow Caledonian University: once for leg measurement to make the knee braces and four times to fill questionnaires and perform gait analysis. Besides, they will wear activity monitor for 3 non-consecutive weeks.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Knee pain before and after each 2-week intervention, measured with 10-cm visual analog scale after each condition of laboratory assessment
2. Knee adduction moment before and after each 2-week intervention - peaks and angular impulse from motion capture system

Secondary outcome measures

1. Knee brace comfort before and after each 2-week intervention, measured with 10-cm visual analog scale after each condition of laboratory assessment
2. Stability feelings before and after each 2-week intervention, measured with 10-cm visual analog scale after each condition of laboratory assessment
3. Symptoms and quality of life before and after each 2-week intervention, measured with KOOS and MOS SF-36 questionnaires subscales
4. Amount of daily physical activities during the second week of each intervention period - four components of physical activity considered by the World Health Organization (WHO) - Frequency, Intensity, Time and Type (FITT) - measured with an activity monitor. We are particularly interested in daily activities and intensities
5. Knee flexion moment before and after each 2-week intervention - peak from motion capture system
6. Lower limb symmetry before and after each 2-week intervention - duration of phases in seconds and percentage, step width and length measured by gait analysis
7. Knee range of motion before and after each 2-week intervention - knee flexion/extension, adduction/abduction, internal/external rotation angles measured by gait analysis

Overall trial start date

01/10/2016

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female aged between 40 and 70 years old having radiological and symptomatic medial knee osteoarthritis (Kellgren-Lawrence grade II, III or IV) according to the American College of Rheumatology’s clinical and radiological criteria (Altman, 1986)
2. Average knee pain > 4/10 (VAS score assessed three times in two weeks before being included)
3. Not currently wearing knee brace
4. Varus knee alignment equal or superior to 2°
5. No or light pain from the hips, ankles, feet or lumbar spine
6. Moderately physically active
7. Able to understand written and spoken English

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Mild knee osteoarthritis (Kellgren-Lawrence grade I)
2. Lateral or patellar knee osteoarthritis
3. Chronic diseases or conditions (e.g., diabetes, osteoporosis, heart disease, hypertension, neurological disorders)
4. Stroke history
5. Inflammatory arthritis (gout, rheumatoid arthritis, psoriatic arthritis etc)
6. Musculoskeletal disorders that could influence their ability to stand and walk
7. Morbid obesity (BMI > 35)
8. Intra-articular corticosteroid/hyaluronan injection in the affected knee in the past 3 months
9. Unstable medication schedule and medication that causes dizziness
10. Severe recent modification of diet
11. Prosthetic implants in the hip, knee or ankle joint
12. Poor skin condition
13. Unable to walk, walk up and down stairs or any condition contraindicating the demands of the gait analysis

Recruitment start date

01/10/2016

Recruitment end date

15/11/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glasgow Caledonian University
Glasgow
G4 0BA
United Kingdom

Sponsor information

Organisation

Peacocks Medical Group Ltd (UK)

Sponsor details

Benfield Park Business
Benfield Road
Newcastle upon Tyne
NE6 4NQ
United Kingdom

Sponsor type

Industry

Website

http://www.peacocks.net/

Funders

Funder type

Other

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

The publication and dissemination plan for this study is:
1. Submission for publication of the study protocol as soon as we receive the ethical approval
2. Dissemination of the results at the OARSI international congress at the end of April 2017
3. Dissemination of the results at the ISPO international congress in May 2017
4. Publication of the results about gait results in the second half of 2017
5. Publication of the results about stairs results in the second half of 2017/beginning of 2018
6. Publication of the results about daily activities in the first part of 2018

Intention to publish date

01/07/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes