Post-operative Comparison Between Standard Gradient Compression Dressing vs. Non-Compressive Bioactive Garment on Pain, Swelling and Range of Motion Following Total Knee Arthroplasty
Phase: NA
Conditions: Osteoarthritis Knees Both
Sponsor: University Hospitals Cleveland Medical Center

 
Post-operative comparison between standard gradient compression dressing vs. 
NonCompressive Bioactive Garment on pain, swelling and range of motion following total knee 
arthroplasty. 
 
NCT04751942 
 
08-09-2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE:  
Post-operative comparison between standard gradient compression dressing vs. 
NonCompressive Bioactive Garment on pain, swelling and range of motion following total knee 
arthroplasty.  
PRINCIPAL INVESTIGATOR:  
Rachael Kilkenny  
216-545-4938  
rachael.kilkenny@uhhospitals.org 
 
Objectives  
This prospective study will evaluate pain, swelling, ROM as well as narcotic use in postoperative 
total knee arthroplasty patients using novel Non-Compressive Bioactive Garment (NCBG) versus 
current standard of care gradient compression stocking (Thrombo-EmbolicDeterrent or TED 
hose). If NCBG proves to be more effective in these outcome areas, it will provide a new and 
comfortable way to reduce patient pain and swelling immediately following surgery. 
Background  
Total knee arthroplasty (TKA) is one of the most popular surgical procedures today. It is 
designed and proven to effectively reduce pain caused by end-stage osteoarthritis. Despite its 
achievements, up to 25% of patients remain dissatisfied after the procedure due to lingering 
pain, amongst other complaints. Post-operative swelling of the knee and leg is thought to be a 
contributor to this persistent pain. 
Traditionally, a standard gradient compression stocking is applied to the knee and leg after 
surgery to reduce this pain and swelling. However, due to ineffectiveness or patient 
noncompliance, compression stockings are often not entirely successful at preventing edema. 
The recently developed NCPS is a lower extremity garment comprised of a technical fabric that 
is thought to be able to prevent edema and reduce pain all in a comfortable, user-friendly 
manner. The purpose of this study is to determine if the NCPS is effective at improving post-
operative pain, swelling, ROM and analgesic use associated with TKA. 
Pain and prolonged recovery time associated with post-operative swelling are two factors that 
contribute to patient dissatisfaction following TKA. Swelling of the knee following TKA is caused 
by intraarticular bleeding and inflammation of the periarticular tissues, which can lead to a 
decrease in functional performance including pain and delayed rehabilitation. In a study by 

Noble et al, 1/3 of dissatisfied patients reported that their knees swelled at least once per week, 
leading to pain and discomfort1 . Decreased quadriceps strength following knee surgery has 
been shown to prolong recovery1-8 . Fahrer et al showed that knee effusions inhibited reflex 
neurons and altered kinetics and muscle activity in quadriceps, which ultimately causes 
decreased strength2 . Holm et al later showed us that knee swelling played a part in post-
operative quadriceps strength following TKA3 . Ultimately, if post-operative swelling can 
effectively be reduced, patient recovery could be expedited and patient satisfaction could be 
improved. 
Compression stockings have been utilized to attempt to reduce post-operative swelling. 
Compression works to prevent swelling by reducing the hydrostatic pressure in the leg. 
Reducing hydrostatic pressure prevents the capillaries from oozing and allows blood to move 
freely from the superficial to the deep venous system, subsequently allowing excess fluid to 
flow away from the interstitial space9 . 
More recently, the use of gradient compression stocking following TKA has come into question 
for its efficacy. While the application of external pressure from these gradient compression 
stocking is beneficial for a period, they are often unable to exert a sufficient amount of pressure 
long enough to prevent painful edema for an extended amount of time. A study by Bowling et al 
showed that these garments showed sufficient compression during the first few hours after 
surgery, but the pressure they applied dropped with time and required daily measurements and 
refitting to maintain appropriate and therapeutic compression10 . This poses a problem not only 
medically, but financially as well. These compression stockings lose their fit so quickly, new ones 
must be prescribed frequently, leading to costly bills for the patient. It’s clear that compression 
stockings are not as effective as once thought when it comes to controlling pain and swelling 
post-operatively. 
A potential solution to the problems posed by traditional compression stocking is the NCPG. The 
garment is comprised of a semi-conductive material ground to nanoparticles that are 
embedded into the fibers, formed into a three-dimensional woven fabric for optimized comfort. 
Instead of relying on compression, NCPS utilizes the body’s own thermal energy to generate 
infrared energy. The infrared energy generated is reflected back at the body and modifies 
cellular activity at the level of the mitochondria through a process known as 
photobiomodulation14-15 . This process of photobiomodulation is hypothesized to improve 
swelling and tissue healing by increasing the activity of mitochondria and the availability of 
cellular energy in the form of ATP. 
This study seeks to determine if NCPS use of infrared energy is more successful at reducing pain 
and swelling following TKA than traditional gradient compression dressing 

Inclusion and Exclusion Criteria 
 
 
Number of Research Participants  
We will enroll 100 subjects throughout all sites involved in the study. 
Recruitment Methods 
Patients will be recruited in the office setting after all non-operative modalities for controlling 
pain associated with end-stage osteoarthritis of the knee have been exhausted. Patients will 
then be presented with the option of total knee replacement. After patient has agreed to 
undergo TKA, patients will then be asked (in a face-to-face setting) if they would like to 
participate in the study. 
Setting  
Research procedures will be conducted in the following locations:  
• Geauga Medical Center in Chardon, OH  
• Beachwood Medical Center, Beachwood, OH  
Patients will be identified and recruited at office locations in Geauga and Beachwood, Ohio 
Consent Process 
Patients will be approached in the office setting after it has been determined that they have 
failed conservative management of advanced knee arthritis. Patients will be in the surgeons’ 
clinic behind closed doors with the performing surgeon and another member of the research 
team. Consent will be obtained in the office after scheduling total knee arthroplasty procedure. 
The consent process is expected to take 30 minutes, but more time is available to ensure that 
patients have all their questions answered prior to signing the consent form. 

Sharing of Results with Research Participants 
☒ Results will not be shared with research participants  
☒ Results will not be shared with research participants’ doctors 
 
Study Design 
Prospective randomized control cohort study 
Study Procedures 
Patients will be enrolled in study prior to surgery, outlined above in the consent process. 
At the time of patient enrollment, A trained member of the research team will measure the 
circumference of the patient’s leg at the mid-thigh, mid-knee and mid-calf with the leg in full 
extension. The patient’s range of motion of the operative leg will be measured in flexion and 
extension. The patient will also fill out a baseline Western Ontario and McMaster Universities 
Osteoarthritis Index (WOMAC) Questionnaire. All measurements and questionnaire answers will 
be recorded on the study data collection sheet and will be transferred to RedCAP. At this time, 
patient’s will be assigned a unique study identifier which will be randomly assigned to the 
experimental or control group. Unique study identifier numbers will start at “#1” and will go up 
by one additional number with every patient enrolled in the study. Even numbers will be 
assigned to the control group and odd numbers will be assigned to the study group, ending with 
50 people enrolled in each group. 
The patient will then go on to have their primary total knee arthroplasty by standard of care 
procedure. Both cruciate retaining and posterior stabilized total knee replacement designs will 
be included in the study. Following closure of the surgical site and placement of a postoperative 
occlusive dressing, the operative leg will be measured once more for circumference and range 
of motion, and the values will be recorded on the study data collection sheet and transferred 
into redcap. The patient will then be placed in their randomized post-operative sleeve/device 
and will be transferred to the PACU and will receive the standard postoperative treatment. 
Pre-operative, intra-operative and post-operative pain protocols will be uniform across 
performing surgeons and will include pre-operative adductor canal block, intra-operative 
posterior capsular injection of local anesthetic, and a standardized post-operative medication 
regimen consisting of: 
• Percocet 5/325mg every 6 hours #28 pills  
• Ibuprofen 800mg every 8 hours x 14 days  
• Carisoprodol 250mg every 8 hours x 14 days  
• Gabapentin 300mg every evening x 14 days  

• Enteric Coated Aspirin 325mg every 12 hours x 28 days (for DVT prophylaxis)  
• Ascorbic Acid 500mg every 12 hours x 14 days  
• Colace 100mg every 12 hours for 7 days 
 
On post-operative day one, patient’s will be seen and evaluated in their inpatient rooms. Their 
leg measurements will be taken again with the knee sleeve/compressive gradient dressing 
pulled down. Measurements will be recorded on the data collection sheet and transferred to 
RedCAP. Patient’s skin will be inspected for any reactions to the sleeve and a standard 
postoperative examination will be performed to ensure no neurovascular compromise, blood 
clots, infections or other post-operative complications. The number of oral narcotic pain 
medications consumed since time of surgery will also be recorded on the data collection sheet 
and transferred into RedCAP. 
Patients will likely be discharged on post-operative day 1. Patients that have not been 
discharged on post-operative day 1 will not be measured on post-operative day 2. 
Sleeves will be worn morning and night for 2 weeks, removing them only for hygiene and 
washing of the sleeve. After 2 weeks, the patient’s will wear the sleeve as much as they can 
tolerate day and night. At 6 weeks, sleeves will be discontinued all together. Final ROM and 
Circumference Measurements will be obtained at 12 weeks post-operative mark. 
Patients will be asked to fill out the WOMAC questionnaire at the time of consent, postoperative 
day 1 and at each subsequent post-operative visit. 
Patients will be seen back at regularly scheduled post-operative visits of 2 weeks, 4 weeks, 6 
weeks and 12 weeks. Patients will be given a WOMAC questionnaire to fill out at each visit. They 
will also give a numerical score for their perceived average pain level since their last visit. 
Patients will also be asked to bring in their narcotic pain pills to the post-operative appointment 
so they can be counted. The WOMAC questionnaire, leg circumference, knee range of motion, 
average pain score and number of remaining narcotic pain pills will be collected on the data 
collection sheet and transferred to RedCAP. Any complications will also be recorded. 
The Reparel leg sleeve is the experimental device being investigated in this study. It is intended 
to improve swelling in the post-operative knee. Further description of the device is provided in 
the background section of this protocol 
EPIC Electronic Medical Records will be used to collect data about patients during their 
inpatient, post-operative stay. Ambulatory EMR will be used in the outpatient setting to collect 
data and track post-operative clinic visits. 

Study Timeline 
 
The enrollment period will be 1 year from the time of the first patient enrolled in the study. The 
enrollment period may be expanded to allow for the investigators to reach their goal of 100 
patients. The total amount of time each patient will be involved in the study will be 12 weeks. 
Patients will only be required to wear the post-operative sleeve/dressing for 6 weeks post-
operatively. Patients will continue to report their narcotic consumption and average pain scores 
for 12 weeks post-operatively. 
Data to be Collected for your study 
 (AFTER consent and HIPAA Authorization have been obtained) 
 
Mid-thigh, mid-knee, and mid-calf measurements in extension  
Range of motion measurements in knee flexion and knee extension  
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)  
Visual analog Pain scale  
Pain medications consumed  
Adverse clinical events including DVT, stroke, PE, surgical site infection, reoperation Name 
Medical record number  
Patient demographics (age, sex, weight, height, BMI) 
 
Data Analysis Plan 
 
Demographics will be reported using descriptives such as count data and percentages. 
Differences between groups at baseline (pre-op) will be reported using two-tailed independent 
ttests for continuous variables, and chi-square or Fisher’s Exact tests for categorical data, as 
appropriate. 
The primary outcomes of range of motion, leg circumference, and pain ratings will be compared 
post-op between conditions using two-tailed independent t-tests. Should clinically relevant 

demographics differ significantly between conditions pre-op (baseline), post-op comparisons 
will instead be conducted using one-way ANCOVAs controlling for differences at pre-op 
(baseline). These comparisons will additionally be made at multiple additional time-points 
throughout a 12- week post-op time period. 
A priori power analyses were calculated for two-tailed independent t-tests for each primary 
outcome, using an alpha of .05, power = .80. Each of these are reported and the average of 
these numbers is used to calculate the final sample size. Clinically significant reductions in pain 
are defined as a 2-point change with a standard deviation of 2.5 using a 10-point scale; 84 
patients were estimated. Clinically significant changes in range of motion are defined as: 10 
degrees of difference from a 0-140 degree estimated range of values. Clinically significant 
changes in leg circumference are defined as: 1 cm difference in leg circumference using a 15-30 
estimated range of values. To identify medium effect sizes of .55, 106 patients were estimated. 
Averaging these values, 99 patients were estimated. To ensure equal numbers of patients in 
each condition, 100 patients will be recruited for this study. 
Risks to Research Participants 
Patients will be monitored for allergic reactions and over compression leading to tourniquet 
effect. There is potential for the experimental garment to not be as effective as the TED hose, 
which would potentially increase swelling. There is risk of discomfort while wearing the 
experimental or standard of care garment. Breach of confidentiality is always a concern anytime 
there is large amounts of patient data being collected, but the risk is being minimized by use of 
locked storage cabinets for hard copy data and RedCAP for electronic recording of data. There 
are no perceived psychological, social, legal or economic risks associated with participation in 
the study. All normal post-operative complications and risks still apply to patients undergoing 
TKA. Risks associated with the use of the experimental device are expected to be incredibly rare, 
minor, short lived and completely reversible. 
Provisions to Protect the Privacy Interests of Research Participants 
Consent will be obtained in a private room at an outpatient clinic facility with solid doors. 
Consent will be done one-on-one with patients and with another trained members of the 
research team present in the room. 
Potential Benefit to Research Participants 
If sleeve is found to be an effective adjunct to decreasing swelling and increase knee ROM, 
patients will likely have less pain post-operatively and have potential for increased range of 
motion. If pain is better improved, patients may use less narcotic pain medication which could 
reduce risk of developing opioid dependence. Patient participation in the study has the 
potential to benefit society. 

Withdrawal of Research Participants 
Patients are able to withdraw from the study at any point in time. If this occurs we will use the 
data we have recorded if possible and the patient will be included in the withdrawn numbers of 
the study. 
Alternatives to Participation 
Patients are still free to undergo TKA without needing to participate in the study using the SOC 
gradient compression dressing 
Costs to Research Participants 
There is no additional cost to the patient. The standard TKA procedure and all associated costs 
will be billable to the patient’s insurance company. The experimental knee sleeve will be 
provided to the patient at no cost. The standard of care gradient compressive dressing will be 
billed to the patient’s insurance. Patients will be responsible for payment of provided services in 
the event of insurance denial. The Non-Compressive Bioactive Garment will be provided at no 
cost by Challenger Health, LLC (dba Reparel). 
Research Participant Compensation 
Patients will not be compensated for their participation in the study. 
Provisions to Monitor the Data to Ensure the Safety of Research Participants 
The data will be monitored every 10 patients to assess for completeness, accuracy and 
adherence to the protocol. We will also be monitoring for any obvious safety concerns that may 
arise. 
Dr. Jonathan Macknin, MD will be the designated Independent Medical Monitor who will review 
halting rules, advise the study team on safety oversight, evaluate adverse events and SAEs, 
review safety reports and protocols deviations related to safety, rights and welfare of patients. 
Drugs or Devices 
Non-Compressive Bioactive Garment– Reparel leg Sleeve Company Name: Challenger Health, 
LLC (dba Reparel) FDA Registration Number: 3012651665 Device Listing Number: D269770 
Product Classification: Class I Medical Device, 510(k) exempt Product Code: FQL, 
Stocking/Medical Support 
 
 
 

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