A 3D printed knee brace to improve symptoms, biomechanics and daily life among medial knee osteoarthritis patients
| ISRCTN | ISRCTN43076496 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43076496 |
| ClinicalTrials.gov (NCT) | NCT02873403 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | AMKNEEBRACE01 |
| Sponsor | Peacocks Medical Group Ltd (UK) |
| Funder | Seventh Framework Programme |
- Submission date
- 27/07/2016
- Registration date
- 16/08/2016
- Last edited
- 20/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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?
January 2017 to June 2017
Who is funding the study?
EU Seventh Framework Programme
Who is the main contact?
Dr Yoann Dessery
yoann.dessery@peacocks.net
Contact information
Scientific
Peacocks Medical Group
Benfield Park Business
Benfield Road
Newcastle upon Tyne
NE64NQ
United Kingdom
 ORCID ID |
0000-0001-5198-356X |
|---|---|
| Phone | +44 (0)191 276 9674 |
| yoann.dessery@peacocks.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blinded crossover superiority randomized controlled trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | A novel additive manufacturing knee brace to improve symptoms, biomechanics and daily life in medial knee osteoarthritis: a crossover randomized controlled trial |
| Study objectives | 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(s) | NHS and Glasgow Caledonian University research ethics committee - approval pending |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
1. Knee pain before and after each 2-week intervention, measured with 10-cm visual analog scale after each condition of laboratory assessment |
| Key secondary outcome measure(s) |
1. Knee brace comfort before and after each 2-week intervention, measured with 10-cm visual analog scale after each condition of laboratory assessment |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 10 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2017 |
| Date of final enrolment | 28/02/2017 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
G4 0BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available because of the project’s commercial nature. The data will be held at Peacocks Medical Group main office. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/05/2021: ClinicalTrials.gov number added.
20/01/2017: The following changes were made to the trial record:
1. The overall trial start date was changed from 01/10/2016 to 01/01/2017.
2. The overall trial end date was changed from 31/03/2017 to 30/06/2017.
3. The recruitment start date was changed from 01/10/2016 to 01/02/2017.
4. The recruitment end date was changed from 15/11/2016 to 28/02/2017.
