To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial
Phase: NA
Conditions: Arthropathy of Knee
Sponsor: The Cleveland Clinic

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Study Title: To Determine the Economic and Functional Impact of Peri-Operative Extension 
Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial 
Study Sponsor:  
Ongoing Care Solutions, Inc. 
Project contact: Linda Lee, Vice President of Ongoing Care Solutions, Inc. 
6545 44th Street North, Unit 4007 
Pinellas Park, Florida 33781 
727.526.0707 (Ph) 
727.525.1424 (F) 
 
Principal Investigator: Carlos Higuera-Rueda, MD 
Regulatory Sponsor: 
This study is an investigator initiated research trial. The study site will be considered its own 
regulatory sponsor and is responsible for internal data monitoring and any study reporting 
required by ClinicalTrials.gov. 
 
 
 

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Background and Significance 
Knee osteoarthritis (OA) is increasing in the United States rapidly due to increased lifespan and 
obesity. The use of unloader bracing has been proposed as an adjunct to current treatments. 
While the use of an unloader brace has not been shown to be beneficial for patients with 
Kellgren-Lawrence grade 1 and 2 osteoarthritis [1], unloader braces have shown benefits in 
patients with end-stage osteoarthritis, Kellegren-Lawrence grade 3 and 4. These benefits include 
increased time to total knee arthroplasty (TKA) and lower number of injections [2]. Indeed, 
pneumatic unloader knee bracing has also been shown to increase strength and function of these 
patients with end-stage knee OA [3]. Typically, the next step for end-stage knee OA is a TKA 
where OA accounts for 94-97% of TKAs [4,5].  
While bracing has been shown to be beneficial for patients with OA in terms of function and 
strength, whether these unloader braces are also similarly beneficial after surgery needs to be 
examined. Therefore we questioned whether wearing a brace that has previously been shown to 
increase strength and function in OA patients can also increase strength and function in patients 
after TKA. 
The primary objective of this study is to determine the efficacy of bracing in improving function 
and rehabilitation prior to and after TKA.  
Additional goal of the study is to assess time taken to normalized function after TKA and its 
impact on cost. Secondary objectives are to quantify and observe pain medication use, swelling, 
muscle strength and girth, and gait efficiency. 
 
Study Design 
Methods 
This a randomized, standard of care controlled study. 
Sample 
Potential subjects will be recruited from a pool of TKA patients presenting to Cleveland Clinic 
orthopedic providers at main campus that may benefit from using a knee brace.. This study aims 
to complete follow-up with 40 patients. 20 out of 40 patients will receive adjunct therapy using 
the OCSI brace. Patients will be allocated to one of these two groups via computer 
randomization. The PI (Dr. Higuera) will be blinded to patient compliance and evaluation during 
data acquisition and statistical analysis. All study patients will receive standard of care therapy 
(pain medications, and other modalities as needed). At home physical therapy will occur at 
standard of care scheduled intervals. Once physical therapy begins at Cleveland Clinic, patients 
in both the control and brace group will receive outpatient Physical Therapy 2 times a week for 
two weeks, then the number of physical therapy visits will be at the discretion of the clinician. 
Patient selection: 
- 
Age: 50 or older 

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- 
Radiographic: Varus or valgus knee deformity less than 10 degrees 
- 
BMI of 40 or less 
 
Research Procedures 
Visit 0: Potential patients will be consented during their office visit with Dr. Mont. Once 
consented, patients will be computer randomized into either the knee brace group or the control 
group. For the knee brace group, measurements will be taken during the clinic visit, an order will 
be written for the brace and sent to Hanger Clinic where they will be in contact with the study 
participant to schedule the brace fitting. The subject can start wearing the brace at this time until 
surgery. 
Visit 1 (6 weeks prior to surgery): Participant will meet with study coordinator and complete 
both questionnaires and physical tests. 
Visit 2 (1 week prior to surgery): Participant will meet with study coordinator and complete both 
questionnaires and physical tests. 
Visit 3 (1 week after surgery): Participant will meet with study coordinator and complete both 
questionnaires and physical tests. The brace will NOT be worn until after staple removal (10 to 
14 days after surgery).  
Visit 4 (6 weeks after surgery): Participant will meet with study coordinator and complete both 
questionnaires and physical tests. 
Visit 5 (12 weeks after surgery): Patient will meet with study coordinator and complete both 
questionnaires and physical tests. At this point, the study time points are complete and the brace 
no longer needs to be worn for the study. 
Chart review: At 9 months, the study team will review participant’s chart for pain medication 
utilization and number of physical therapy visits during the study. 
 
Visit 0 
Office visit 
(scheduling 
surgery) 
 
Visit 1 
6 weeks 
prior to 
surgery 
(±4 weeks) 
Visit 2 
1 week 
prior to 
surgery 
(±1 
week) 
Visit 2 
1 week 
after 
surgery 
(±1 
week) 
 
Visit 3 
6 weeks 
after 
surgery 
(±2 
weeks) 
Visit 4 
12 weeks 
after 
surgery 
(±2 
weeks) 
9 
months 
After 
surgery 
(chart 
review) 
Informed 
Consent 
X 
 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
 

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Timed up and 
go (TUG) test 
 
X 
X 
X 
X 
X 
 
Timed stair-
climb test 
 
X 
X 
X 
X 
X 
 
Single-limb 
stance time 
(bilateral) 
 
X 
X 
X 
X 
X 
 
6 minute walk 
test 
 
X 
X 
X 
X 
X 
 
AROM, 
PROM 
 
X 
X 
X 
X 
X 
 
Knee Society 
objective score 
 
X 
X 
X 
X 
X 
 
Knee Society 
functional 
Score 
 
X 
X 
X 
X 
X 
 
KOOS (Jr) 
 
X 
X 
X 
X 
X 
 
HSS scale 
 
X 
X 
X 
X 
X 
 
Pain score on 
visual analog 
scale (rest) 
 
X 
X 
X 
X 
X 
 
Pain score on 
visual analog 
scale (activity) 
 
X 
X 
X 
X 
X 
 
Pain 
medications 
utilization 
 
X 
X 
X 
X 
X 
X 
Number of 
therapy visits 
 
 
 
 
 
 
X 
 
 
For this research study, we will ask you to fill out some additional physical tests will be 
performed. These tests include: 
o Timed up and go (TUG) test: standing up from seated position and walking to a 
designated line, walking back, and returning to seated position 
o Timed stair-climb test: walking up and down stairs 
o Single-limb stance time (bilateral): standing on one leg unassisted 

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o 6 minute walk test: distance walked in 6 minutes 
 Patient reported outcomes will also be assessed using multiple validated questionnaires 
o Knee Society Score (KSS) 
o Knee Injury and Osteoarthritis Outcome Score (KOOS Jr) 
o HSS scale 
o Visual Analog Scale (Pain score) 
 
Participant Compliance 
Study participants will be given a pedometer and notebook supplied by the sponsor to record 
daily steps. This will be used to monitor compliance with physical therapy and the use of the 
brace as it is expected there should be increased activity over time. 
 
Data Analysis 
 
Descriptive statistics (mean, standard deviation, and coefficient of variation) will be used to 
compare the demographics between the two cohorts. Functional metrics will be compared pre- 
and post-surgery at 0- and 3- months. Unless otherwise indicated, all testing of statistical 
significance will be two-sided, and a difference resulting in a p-value of less than or equal to 
0.05 will be considered statistically significant. Also, after each analysis, General Linear Models 
(GLM) will be used to control for possible confounders, including BMI, gender, age, and 
ethnicity. 
 
 
Adverse Events and Data Monitoring Committee 
 
Procedural safety will be documented in this study through patient and surgeon reported adverse 
events. ARs will be documented for all ceases in this study. 
 
An unanticipated problem involving risks to participants or others is any event that (1) is 
unforeseen, (2) caused harm or placed a person at increased risk of harm, and (3) is related to the 
research procedures. 
 
An Adverse Event (AE) is any untoward or unfavorable medical occurrence, including any 
abnormal sign (for example, abnormal physical exam or laboratory finding), symptoms, or 
disease. Adverse events can encompass both physical and psychological harms. 
 
An Internal Adverse Event (AE) is an untoward medical occurrence, which occurs to participants 
in research conducted by Cleveland Clinic and/or Cleveland Clinic is the IRB of record. 
 
External Adverse Event (AE) is an untoward medical occurrence experienced by subjects 
enrolled at other institutions for the same study approved at Cleveland Clinic or a different study 
using the same study drug/device. 
 
A Serious Adverse Event (SAE) is any adverse experience that results in any of the following 
outcomes: 
 Death 

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 A life-threatening experience 
 Inpatient hospitalization or prolongation of existing hospitalization 
 A persistent or significant disability/incapacity 
 A congenital anomaly/birth defect 
 Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered a serious adverse experience when, based upon 
appropriate medical judgment, they may jeopardize the patient or subject and may 
require medical or surgical intervention to prevent one of the outcomes listed in this 
definition. 
 
An Unexpected Adverse Event means any AE not previously known or included in the consent 
form or other risk information. 
 
Related/Possibly Related means there must be reasonable evidence to suggest the event was 
caused by the device or investigational intervention. 
 
1) Internal Serious Adverse Events (events that occur to participants enrolled in research 
being conducted by Cleveland Clinic and when Cleveland Clinic is the IRB of record) 
must be promptly reported to the IRB using the IRB AE report form within 10 working 
days from discovery/awareness which meet any of the following criteria as assessed by 
the PI/Co-I: 
a. Serious, unexpected, and related/possibly related 
b. AEs determined to be occurring at a significantly higher frequency or severity 
other than expected 
c. Other unexpected AE’s, regardless of severity, that changes the risk benefit ration 
of the study and results in changes to the Research protocol or Informed Consent 
process/document 
d. All internal SAEs are also reported at continuing review using the AE Summary 
Log 
2) External Serious Adverse Events (events experienced by subjects enrolled at other               
institutions for the same study approved at Cleveland Clinic or a different study using the 
same study device/drug) are reportable to the IRB using the IRB AE Report Form within 
10 working days from discovery/awareness when: 
a. The External SAE report includes reasonable evidence as assessed by a central 
monitoring   entity [Coordinating or Statistical Center, or a Data Safety 
Monitoring Board (DSMB) or Data Monitoring Committee (DMC)] that the event 
is Serious, Unexpected, and Related/Possibly Related AND   places the subjects 
or others at a greater risk of physical or psychological harm than was previously 
known or recognized. This will require a change in the protocol and/or consent 
document. 
b. External SAE reports provided by the Sponsor to the investigator indicating the 
event is Serious, Unexpected and Related/Possibly related but without reasonable 
evidence or DSMB/DMC determination  of greater risk are not reportable to the 
IRB within the 10 day window. Without Sponsor evidence or assessment the 
implications of the event cannot be determined by the research team and therefore 

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need not be reviewed. These SAE’ shall be placed on the AE Summary log to be 
submitted at the annual continuing renewal. 
3) DEATHS are to be reported to the IRB using the IRB AE Report Form according to the 
following guidelines: 
a. Internal Death 
i. Related/possibly related whether expected or unexpected– within 5 
working days from discovery/awareness 
ii. not related and expected – at time of continuing review 
iii. Not related and unexpected – at time of continuing review except cancer 
studies 
b. External Death 
Related/possibly related and unexpected – within 5 working days from 
discovery/awareness not related whether expected or unexpected – at time of 
continuing review related/possibly related and expected – at time of continuing 
review 
c. ALL Deaths are also reported at time of continuing review using the AE summary 
log. 
4) Non-serious Adverse events (Internal and External) that are both Related/Possibly related 
and unexpected are reported on the AE Summary Log at time of continuing review to 
assess trends. 
5) An IRB staff (a qualified, licensed practitioner assigned to this function by the IRB chair 
and IRB Executive Director) reviews Adverse Event Reports to determine whether they 
represent Unanticipated Problem Involving Risks to Participants or Others. Events that 
are assessed, by either the IRB Staff or Investigator, to place subjects or others at a 
greater risk of harm than was previously known or recognized, or changes the risk/benefit 
ratio of the study, or requires a change in the protocol and/or consent document are 
referred to Full Board for review under Policy #70. 
6) Events that do not involve risk to Participants or Others or changes to the informed 
consent or protocol do not require further review. Investigators are informed of the 
determination and the IRB file is updated. 
7) The AE Summary Log is reviewed by the IRB at the time of continuing review to 
identify trends in frequency and severity which may impact subject safety. 
 
 
This study is an Investigator Initiated research trial. Each study site will be considered its 
own regulatory sponsor and is responsible for internal data monitoring and any study 
reporting required by ClinicalTrials.gov. 
 
 
 
 

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References: 
1) Mont MA, Cherian JJ, Bhave A, Starr R, Elmallah RK, Beaver WB Jr, Harwin SF. 
“Unloader Bracing for Knee Osteoarthritis: A Pilot Study of Gait and Function.” Surg 
Technol Int 2015; 27:287-93. 
2) Chughtai M, Bhave A, Khan SZ, Khlopas A, Ali O, Harwin SF, Mont MA. “Clinical 
Outcomes of a Pneumatic Unloader Brace for Kellgren-Lawrence Grades 3 to 4 
Osteoarthritis: A Minimum 1-Year Follow-Up Study.” J Knee Surg; 29(8):634-638. 
3) Cherian JJ, Bhave A, Kapadia BH, Starr R, McElroy MJ, Mont MA. “Strength and 
Functional Improvement Using Pneumatic Bracing with Extension Assist for End-Stage 
Knee Osteoarthrtitis: A Prospective, Randomized trial. J Arthroplasty 2015. 30(5):747-
753. 
4) Lawson EH, Gibbons MM, Ingraham AM, Shekelle PG, Ko CY. “Appropriateness 
criteria to assess variations in surgical procedure use in the United States. ArchSurg. 
2011, 146:1433-1440 
5) Carr A, Robertson O, Graves S, Price A, Arden N, Judge A, Beard D. “Knee 
replacement” Lancet 2012, 379:1331-1340