Osteoarthritis, Knee Clinical Trial
Official title:
Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients
NCT number | NCT04056845 |
Other study ID # | HAREC |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | June 30, 2021 |
To investigate whether the use of valgus knee brace is useful for patients with medial knee osteoarthritis.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 30, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age between 40-80 - History of symptomatic medial unicompartmental knee osteoarthritis > 6 months - Willingness to wear the knee brace for a minimum of 4 hours per day during daily activities - Understanding of the Chinese language - Ethnic Chinese patients Exclusion Criteria: - Symptomatic knee osteoarthritis affecting more than one compartment - Clinical and radiological signs of osteoarthritis over the lateral compartment or patello-femoral joint - Significant knee effusion or soft tissue compromise preventing long-term knee brace use - Obesity (BMI>30) - Previous surgery on the affected knee other than diagnostic arthroscopy with debridement, soft tissue reconstruction, menisectomy - Peripheral vascular disease of the lower limb |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Hospital Authority | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Hospital Authority, Hong Kong |
Hong Kong,
Fu HC, Lie CW, Ng TP, Chen KW, Tse CY, Wong WH. Prospective study on the effects of orthotic treatment for medial knee osteoarthritis in Chinese patients: clinical outcome and gait analysis. Hong Kong Med J. 2015 Apr;21(2):98-106. doi: 10.12809/hkmj144311. Epub 2015 Mar 10. — View Citation
Moyer RF, Birmingham TB, Bryant DM, Giffin JR, Marriott KA, Leitch KM. Valgus bracing for knee osteoarthritis: a meta-analysis of randomized trials. Arthritis Care Res (Hoboken). 2015 Apr;67(4):493-501. doi: 10.1002/acr.22472. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in pain | Visual Analog Scale (VAS) for pain from 0 to 10, with higher value signifying worse pain control | At 16 weeks after the initiation of study | |
Secondary | Improvement in knee functioning | The Western Ontario and McMaster Universities Osteoarthritis Index | At 16 weeks after the initiation of the study |
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