A 3D printed knee brace to improve symptoms, biomechanics and daily life among medial knee osteoarthritis patients

Not Applicable

Completed

• Conditions: Medial tibiofemoral knee osteoarthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN43076496
• Lead Sponsor: Peacocks Medical Group Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-16
• Study Completion: 2017-06-30
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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