Can Proprioceptive Knee Brace Improve Functional Outcome Following Total Knee Arthroplasty?
Phase: NA
Conditions: Knee Osteoarthritis
Sponsor: Chinese University of Hong Kong

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A. Study Title: 
Can proprioceptive knee brace improve functional outcome following total knee arthroplasty? 
B. 
Introduction: 
Osteoarthritis is among the most prevalent form of degenerative joint disease in arthritis (1). The World 
Health Organisation identified osteoarthritis as one of the top ten most disabling cause of disease in 
developed countries (2), and the single most common cause of disability for elderly persons (3). In fact, 
worldwide statistics for men and women over 60 years of age with signs of symptomatic osteoarthritis 
are estimated to be at 9.6% and 18.0% respectively (2). In Hong Kong, the latest census revealed that 
514,000 people suffer from degenerative arthritis, representing 0.7% of the population (4). Although 
these values are much lower than the international figures reported by the WHO,  it is inevitable that the 
prevalence of osteoarthritis will continue to rise with an increasing trend of obesity and an aging 
population in Hong Kong (5, 6). Similar to any other chronic disease with wide prevalence, the impact of 
osteoarthritis translates to a substantial socioeconomic burden on a societal level.   
Total knee arthroplasty has become the gold standard to manage the pain and disability associated with 
end-stage arthritis who have exhausted all conservative measures.  Although contemporary advances in 
prosthesis design, surgical techniques, postoperative rehabilitation regimes have hasten patient’s 
recovery, the restoration of proprioception and neuromuscular control is often prolonged despite solid 
rehabilitation regimes(7, 8) .  
Knee bracing is one of the non-pharmacological modalities designed to evenly distribute load and provide 
proprioceptive feedbacks for those with knee injuries or knee pain (9-11). There are four categories of 
knee braces for the purpose of prophylactic, functional, rehabilitative and unloader/off-load. This study 
will mainly be focusing on the effects of the unloader/off-loader brace. Previous studies have 
demonstrated the effects on alteration of kinematic variables, including range of movement (p=0.002), 
speed of walking (p<0.001) and knee adduction moment (p=0.001) for knee injuries and osteoarthritis 
(12, 13) as a part of the conservative management protocol. However, there have few studies (14) that 
investigated whether proprioceptive knee bracing has any role in functional recovery post total knee 
arthroplasty.  
C. Aims and Hypotheses to be tested: 
This proposed research study aims to conduct a randomised control trial to evaluate the functional 
outcomes of the utilisation of proprioceptive knee brace following total knee arthroplasty.  
D. Description of the knee unloader brace: 
For the intervention group that randomly consisted of 15 subjects will be using a design of knee brace 
(Reaction Web®; DonJoy, Vista, CA). The elastomeric web design helps to reduce pain by dispersing load 
across the knee. The web acts like a spring to absorb shock and shifts the peak loads away from the painful 
area of the knee. Elastomeric web acts to dynamically stabilise the patella on all sides, bringing the patella 
into proper tracking position to reduce pain for patients with general patellofemoral instabilities. Reaction 
Web® has dual-axis hinges that are flexible, creating synergy with the elastomeric web for optimal fit and 
support, and providing energy dispersion to the knee.    
(The above information was retrieved from DonJoy website) 

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E. Plan of Investigation: 
30 patients with end stage knee OA who are schedule for TKA will be recruited via face to face promotion 
from the Li Ka Shing Orthopaedics Specialist clinic at the Department of Orthopaedics and Traumatology 
at Prince of Wales Hospital (PWH) Hong Kong. 15 patients will be randomly allocated to each of the 
treatment (proprioceptive knee brace + routine post-operative procedures) and control (routine post-
operative procedures) groups.   
Part 1a. Preliminary assessment on patients from Prince of Wales Hospital Orthopaedics specialist 
clinic based on inclusion and exclusion criteria 
Part 1b. Preliminary assessment on patients [i.e. Basic demographics, Knee Function Assessment, 
Outcome Measurement Questionnaires] 
Part 1c. Randomise allocation between treatment and control group 
Part 2. Peri-operative assessment [i.e. Length of Hospital Stay]   
Part 3.  Distribution of knee brace (available to treatment arm) post-operative 2 to 4 week recovery 
Part 4a. Post-operative 6 weeks Assessment 
Part 4b. Post-operative 6 months Assessment 
Part 4c. Post-operative 12 months Assessment 
 
F. Methods: 
 
(1) Post recruitment assessment 
After recruitment, oral and written consents will be obtained from individuals who agree to participate in 
the study. The recruitment period will last for 12 months and the whole project period is 2 years in total. 
Basic Demographics, Knee Function Assessment and Physical Activity Questionnaires will be carried out. 
 
Inclusion criteria - Patients are included in the experiment if 
(1) Adult (age over 18 years old) underwent Total Knee Arthroplasty within 2 to 4 weeks; 
(2) Adult who is able to provide written consent and compliance with treatment and assessment 
regime 
Exclusion criteria - Patients are excluded from the experiment if 
(3) Patients with disabilities, wheelchair dependence for mobility;  
(4) Underwent revision Total Knee Arthroplasty; 
(5) Found with complication wounds following surgery; 
(6) Diagnosed with comorbidities e.g. inflammatory arthritis, obesity, dermatological disorders that 
might affect their compliance to treatment;     
(7) Do not fit to the sizes of knee braces; 
(8) Not to given written consent and be non-compliance with the treatment and assessment regime 
Sample Size Estimation 

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The sample size estimation was calculated using GPower 3.1 based on the yearly admission total knee 
replacement cases at Prince of Wales hospital. Effect size was calculated at 0.5. With 95% power and an 
alpha value of 0.05, 12 participants are required for each of the study control and intervention groups. An 
additional 25% will be added to account for possible attrition. Total 30 (15x2) subjects will be recruited 
for this study. 
Basic Demographics 
 
Pre-operation baseline demographics will be collected for inter-patient comparisons: 
1. Gender 
2. Age 
3. Height, Weight and Body Mass Index 
4. Duration of Symptomatic Knee OA 
5. Ethnicity 
 
Knee Function Assessment 
 
1. Speed of motion   
The 10-meter timed walking test is a well-established and documented test for assessment for gait speed 
in patients. However, due to space limitations and the exhaustive nature of the test for patients with OA, 
the 6-meter test timed walking gait test has been documented to be a valid and reliable substitute. 
Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance 
will be measured. (<7.5 seconds is normal). 
The Time up and go test (TUG) is to determine fall risk and measure the progress of balance, sit to stand 
and walking. Patients will be asked to stand up from a chair, walk as quickly as possible in their a safe and 
most comfortable gait until they pass to 3 meters (10 feet) end of marked course with both feet. Turn 
around and walk back to the chair, time will be counted to the moment until the back of patients touches 
the back of the chair. (≤ 10 seconds = normal; ≤ 20 seconds = good mobility, can go out alone, mobile 
without gait aid; ≤ 30 seconds = problems, cannot go outside alone, requires gait aid; ≥ 14seconds indicates 
high risk of falls) 
2. Range of motion  
The active range of motion test predicts the mobility of the joint by measuring the amount of active knee 
extension and flexion. “For measurement using the goniometer, 1 arm of the goniometer is placed parallel 
to the shaft of the femur lining up with the greater trochanter, and the other arm is placed parallel to the 
shaft of the lower leg lining up with the lateral malleolus of the fibula. The axis of the goniometer is placed 
over the lateral femoral epicondyle. Knee extension: The patient is supine. The heel of the limb of interest 
is propped on a bolster, assuring the back of the knee and calf are not touching the support surface. The 
patient is asked to actively contract the quadriceps. The amount of knee extension is recorded with the 
goniometer. Knee flexion: The patient is prone. The patient flexes the knee as far as possible. The amount 
of knee flexion is recorded with the goniometer.”(15) 
 
 
 

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3. Knee Stability test 
KT-1000 will be used at the assessing of knee laxity as it provides an objective evaluation of knee 
stability resulting from the automated anterior drawer test it performs. 
4. Knee extensor/flexor strength 
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee 
extension movement in a sitting position with both feet free from ground, and the hip and knee joint 
flexed at 90%. The optimal isometric force of the knee extension/flexion movement is measured by the 
dynamometer attached at the malleoli level with a strap. 
The measurements will be taken at maximum force for three times. 
 
Physical Activity Questionnaires 
 
Patient’s health related quality of life (HRQoL) will be assessed through three validated and reliable 
questionnaires (i.e. SF-12, WOMAC). 
 
1. Short-Form 12 (SF-12) 
The SF-12 health survey uses 12 questions to measure patient’s functional health and well-being from a 
patient’s point of view. It is reliable and validated measure that summaries the patients’ physical and 
mental health. 
 
2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 
The WOMAC questionnaire is a questionnaire that measures patient’s pain, stiffness and physical function 
and can be summed up into a score out of 96. A high score indicates a more disabled participant. 
 
3. The Forgotten Joint Score-12  
The FJS-12 comprise measures for the assessment of joint-specific patient-reported outcome in their 
ability to forget about a joint as a result of successful treatment. Join awareness can be simply defined as 
any unintended perception of a joint. This may include strong sensation sensations like pain, but also 
includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort.  
 
4. Knee Society Score (KSS), Knee Society Function Score (KFS) 
The KSS is an instrument assessing patient’s pain and functionality based on a series of questions 
interviewed by a clinician. The validated questionnaire combines the objective physician derived 
component with a subjective patient derived component which evaluates pain, functionality, satisfaction 
and fulfillment of expectations. The results will be calculating the total score with 100 being the highest 
and 0 the lowest. 
 
 
 
 
 
 
Physical Assessments 
Prep-op  
6 weeks  
6 months 
12 months 

Ver1.1 _Proprioception knee brace Protocol_ 20220504 
 
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6m gait  
✓ 
✓ 
✓ 
✓ 
TUG 
✓ 
✓ 
✓ 
✓ 
Active ROM 
✓ 
✓ 
✓ 
✓ 
KT-1000 
✓ 
✓ 
✓ 
✓ 
Knee extensor/flexor 
✓ 
✓ 
✓ 
✓ 
SF12 
✓ 
✓ 
✓ 
✓ 
WOMAC 
✓ 
✓ 
✓ 
✓ 
KSS & KFS 
✓ 
✓ 
✓ 
✓ 
Compliance assessment 
✓ 
✓ 
✓ 
✓ 
Satisfaction Survey 
✓ 
✓ 
✓ 
✓ 
 
 
Clinical Research Compliance assessment will be conducted to measures the period and amount of time 
designated knee brace has been put on as interventional means. It is also recorded to the attendance of 
routine post-operative procedures of physiotherapy training one might receive.  
Patients satisfaction Survey is to be recorded in terms not only how well to the quality of care patient 
was being treated, but to also the content a patient is with the care they received.  
 
Data Processing and Statistical Analysis: 
Demographic characteristics will be demonstrated using Student t-test or Chi-square test for continuous 
data and categorical data respectively where appropriate. The accuracy of primary measurements 
between the treatment (proprioceptive knee brace + routine post-operative procedures) and control 
(routine post-operative procedures) groups at the 4 time points (Pre-operative, 6 weeks, 6 months, 12 
months) will be compared using ANOVA. Secondary outcomes and different types of patient-oriented 
quality of life questionnaires collected at the 4 time points will be compared using ANOVA likewise. All 
statistical analysis will be carried out using IBM SPSS version 25 (Armonk, NY:IBM Corp). 
Primary outcome:  
● 
Speed/range of motions of the knee. 
Secondary outcome:  
● 
Patient’s clinical outcome (knee stability and function), HRQoL and satisfaction. 
Complications and adverse events.  
 
 
This study is stated in compliance with Declaration of Helsinki and ICH-GCP. 
 
 
 
 

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