Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients
Phase: NA
Conditions: Osteoarthritis, Knee
Sponsor: Hospital Authority, Hong Kong

Version 1 dated 19 June 2019 
 
 
Research proposal 
 
Prospective randomized study on the effects of valgus knee brace for 
knee osteoarthritis in Chinese patients 
 
Principal Investigator: 
Dr WAN Keith Hay-Man, Resident Specialist  
 
List of Co-investigators: Dr CHOI Siu Tong, Associate Consultant 
 
Dr WONG Kam Kwong, Consultant 
 
 
 
 
Department of Orthopaedics and Traumatology, Kwong Wah Hospital 
 
 
 
Last updated on 19th June 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version 1 dated 19 June 2019 
 
 
 
TWGH Research Fund 2018/2019 (Research Project) 
Research proposal 
 
Prospective randomized study on the effects of valgus knee brace for 
knee osteoarthritis in Chinese patients 
 
Principal Investigator: 
Dr WAN Keith Hay-Man, Resident Specialist  
 
List of Co-investigators: Dr CHOI Siu Tong, Associate Consultant 
 
Dr WONG Kam Kwong, Consultant 
 
 
 
 
Department of Orthopaedics and Traumatology, Kwong Wah Hospital 
 
 
Aim of study 
 
Osteoarthritis of the knee is the commonest type of arthritis affecting both the middle age 
and geriatric population, which poses a huge burden to our in-patient and out-patient 
orthopaedic services.  Conservative treatment like physiotherapy and analgesic provide 
temporary symptomatic relief.  Surgical treatment like high tibial osteotomy and knee 
arthroplasty are not without major potential surgical risks and implant-related complications. 
 
Orthotic treatment can theoretically alter the loading to the knee joint and help to reduce the 
symptoms and disease progression.  Small scale biomechanical studies have demonstrated 
such effects with the use of valgus knee brace (2-4).  Though prospective clinical outcome 
studies on Chinese patients in our locality are lacking.   
 
Valgus knee brace is a non-pharmaceutical, non-invasive option for knee pain.  Using a three-
point leverage the unloader brace is to shift the stress away from the arthritic area to the 
normal portion of the knee, maintains good alignment and stability and thus provides 
significant pain relief during daily activities.  It has been commonly used as a first line 
management option in other countries. 
 
Our aim is to perform a prospective randomized study to look at the difference in outcome 
measures in osteoarthritic patients with the use of valgus knee brace, on top of the usual 
regime of conservative treatment.   
 
Materials and Methods  
 
The present study protocol will be submitted to the Research Ethics Committee (Kowloon 
Central/Kowloon East) for review.  It would be a multi-disciplinary project with the 

Version 1 dated 19 June 2019 
 
contribution from the physiotherapy department and occupational therapy department.   
 
We aim to recruit 45 consecutive patients with symptomatic isolated medial knee 
osteoarthritis, who are referred to our knee arthritis clinic as new cases.  We expect a drop-
out rate of 10%.  Upon randomization into a 1:1 ratio using sequentially numbered sealed 
envelopes, patients will be assigned to either a knee brace group, or a control group. Patients 
in control group will receive conservative treatment of physiotherapy with a standardized, 
protocol-driven knee osteoarthritis programme.  Patients in the knee brace group will receive 
the same treatment, with the additional use of valgus off-load knee brace (OA corrector).  
They are advised to wear the knee brace for a minimum of four hours a day, excluding the 
time when they are sleeping.  To ensure proper usage of the knee brace patients in the knee 
brace group will have a demonstration session by occupational therapists.  They will be asked 
to put on the knee braces in front of the therapists at the beginning of the study period. 
Patient will be followed up at 8 weeks and 16 weeks. The time frame for study will be 16 weeks.   
 
At the end of the study, upon request, we may consider giving the knee braces to the patients 
if they find them useful. 
 
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 
 
Outcome measures would include assessment of pain, including visual analogue scale (VAS), 
analgesic use (number of times required per week); stability in terms of improvement of 
limping gait assessed by orthopaedic surgeons; and functioning by the Western Ontario and 
McMaster Arthritis Index (WOMAC).  ANOVA test will be used for statistical analysis.  Outcome 
assessors will be blinded. 
 
Implication 
 

Version 1 dated 19 June 2019 
 
Osteoarthritis of the knee is not only a common and debilitating problem affecting the 
geriatric population, it is also not uncommonly seen in the middle age patient group with 
significant hindrance to their quality of life. 
 
The current literature recommendations for the use of orthotic treatment for medial 
compartment knee osteoarthritis are still varied (5,6).  Valgus off-load knee bracing is a non-
invasive, non-pharmaceutical option for medial knee osteoarthritis.   
 
 By performing this prospective study we would be able to tell if there is any additional 
benefits with the use of bracing in patients with medial compartment knee osteoarthritis.   
 
 
Time-frame for the research  
1/9/2019 - 31/12/2020 
Recruit 45 consecutive patients with medial compartment knee 
osteoarthritis 
1/1/2021 – 31/3/2021 
Data analysis for the study 
1/4/2020– 30/6/2020 
Progress report and result publication of the study 
30/6/2021 
Final report submission date to REC(KC/KE) 
 
 
Ethical Concern 
Personal data is kept anonymous with identifiable code on study document and will follow 
the HA policy on handling of patient data privacy.  They would be locked in cabinets where 
the department or ward keeps patients’ confidential information.  Electronic data should be 
saved in secured computer of the hospital with restricted access. 
 
 
Reference: 
 
1. 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;21:98–106 
2. Pollo FE, Otis JC, Backus SI, Warren RF, Wickiewicz TL. Reduction of medial 
compartment loads with valgus bracing of the osteoarthritic knee. Am J Sports Med 
2002;30:414-21. 
3. Lindenfeld TN, Hewett TE, Andriacchi TP. Joint loading with valgus bracing in patients 
with varus gonarthrosis. Clin Orthop Relat Res 1997;344:290-7. 
4. Pagani CH, B.hle C, Potthast W, Brüggemann GP. Shortterm effects of a dedicated knee 
orthosis on knee adduction moment, pain, and function in patients with osteoarthritis. 
Arch Phys Med Rehabil 2010;91:1936-41 
5. Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management 
of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus 
guidelines. Osteoarthritis Cartilage 2008;16:137-62. 

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6. Jevsevar DS, Brown GA, Jones DL, et al. The American Academy of Orthopaedic 
Surgeons evidence-based guideline on: treatment of osteoarthritis of the knee, 2nd 
edition. J Bone Joint Surg Am 2013;95:1885-6.