PROvision of braces for Patients with knee OsteoArthritis (PROP OA): a randomised controlled trial

Not Applicable

• Conditions: Knee osteoarthritis (symptomatic); Musculoskeletal Diseases; Gonarthrosis [arthrosis of knee]

• Registration Number: ISRCTN28555470
• Lead Sponsor: Keele University

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33771832/ (added 13/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-26
• Last Update Posted: 29 January 2024
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 466

Inclusion Criteria

Current inclusion criteria as of 14/05/2021:
1. Aged 45 years and over
2. Residing in England
3. Clinically significant knee pain on weight bearing (NRS >=4)
4. With or without knee instability or buckling
5. Able to have knee x-ray
6. Able to read and write English
7. Access to a mobile phone that can receive SMS text messages
8. Able to give full informed consent
9. Willing to participate
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Previous inclusion criteria:
1. Aged 45 years and over
2. Residing in England
3. Clinically significant knee pain on weight bearing (NRS >=4)
4. With or without knee instability or buckling
5. No morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes
6. Able to have knee x-ray
7. Able to read and write English
8. Access to a mobile phone that can receive SMS text messages
9. Able to give full informed consent
10. Willing to participate

Exclusion Criteria

Current inclusion criteria as of 14/05/2021:
1. Red flags in the history or clinical examination that may indicate further investigation or referral for possible serious underlying pathology
2. Vulnerable individuals (e.g. in palliative phase of care for cancer, unstable mental health disorders)
3. Inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis)
4. Symptoms not attributable to knee osteoarthritis
5. Previous total knee replacement, high tibial osteotomy, or autologous cartilage implantation
6. On the waiting list for TKR/THR within the next 6 months
7. Unwilling to wear a knee brace
8. Brace size unavailable for leg circumference
9. Knee brace contraindicated (superficial wounds where the knee brace would reside, psoriasis, eczema or poor circulation, arterial insufficiency, or severe varicosities that could result in skin at risk with regular brace wear, a history of thrombophlebitis in either leg)
10. Recent/routine knee brace wear within the last 3 months
11. Nursing home resident
12. Unable to attend clinic
13. Close family member already a trial participant
14. Knee injection in the last 3 months
15. Course of physiotherapy in the last 3 months
16. Significant neurological disorder (e.g. stroke, Parkinson’s disease, multiple sclerosis, dementia)
17. Fibromyalgia
18. Autologous cartilage implantation in last 12 months in the knee to be treated
19. Significant fixed flexion deformity that prevents fitting of brace

_____

Previous exclusion criteria:
1. Red flags in the history or clinical examination that may indicate further investigation or referral for possible serious underlying pathology
2. Vulnerable individuals (e.g. in palliative phase of care for cancer, unstable mental health disorders)
3. Inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis)
4. Symptoms not attributable to knee osteoarthritis
5. Previous total knee replacement, high tibial osteotomy, or autologous cartilage implantation
6. On the waiting list for TKR/THR within the next 6 months
7. Unwilling to wear a knee brace
8. Brace size unavailable for leg circumference
9. Knee brace contraindicated (superficial wounds where the knee brace would reside, psoriasis, eczema or poor circulation, arterial insufficiency, or severe varicosities that could result in skin at risk with regular brace wear, a history of thrombophlebitis in either leg)
10. Recent/routine knee brace wear within the last 3 months
11. Nursing home resident
12. Unable to attend clinic
13. Close family member already a trial participant
14. Knee injection in the last 3 months
15. Course of physiotherapy in the last 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified