Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA

Study Overview
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Brief Summary
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This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.

Official Title
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A Randomized Controlled Trial Evaluating Edema and ROM Using Negative Pressure Therapy Over Closed Incisions and Surrounding Soft Tissue Versus Standard Surgical Dressings in Bilateral Total Knee Arthroplasty: A Pilot Study

Conditions
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Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases, Musculoskeletal Diseases, Edema Leg, Joint Pain, Arthritis Knee

Intervention / Treatment
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* Device: Closed Incision Negative Pressure Therapy (ciNPT)
* Device: Standard Silver-containing Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: is at least 22 years of age on the date of informed consent. can independently provide informed consent. requires and is scheduled to undergo a simultaneous, bilateral, primary TKA. is willing and physically capable of undergoing a simultaneous, bilateral, primary TKA with or without replacement of the patella. is willing and able to return for all scheduled study visits. Exclusion Criteria: is pregnant or lactating. has signs of an infection in the area of either knee or has signs of a systemic infection at the time of surgery. is a chronic opioid user, defined per the CDC guidelines as opioid use for >3 months, at the time of enrollment. has a current diagnosis of lymphedema in either leg. has signs, symptoms, or a current diagnosis of venous insufficiency in either leg, as determined by the investigator's review of the subject's medical history. has a history of clotting disorder or prior history of deep vein thrombosis will undergo a unilateral TKA. will undergo a staged, bilateral TKA. has had previous knee replacement surgery. has received a corticosteroid injection into either knee within 30 days of surgery. undergoes a simultaneous, bilateral TKA with a planned different incision type on each knee (eg, midline incision vs. medial parapatellar incision). has known sensitivity to the study product components (drape and/or dressing materials in direct contact with the closed incision or skin). has known sensitivity to silver. is enrolled in another interventional clinical study. has skin cancer localized at or in proximity to the incision site. does not have access to an electronic device (smartphone, iPad, or computer) on a daily basis to complete online assessments. has condition(s) that, in the opinion of the investigator, cause the subject to be an overall health risk that is unsuitable for the surgery. has condition(s) that, in the opinion of the investigator, will impact study endpoints (eg, hemophilia or autoimmune disorders) or the ability to comply with study procedures. Intra-Op Exclusion Criteria: does not receive a total knee replacement for first knee. For example, a partial or uni-compartmental knee replacement is performed has a surgical incision that would preclude placement of either dressing onto the knee has a TKA resulting in a muscle flap

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: One leg receives ciNPT and the other leg receives standard silver containing dressing.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed Incision Negative Pressure Therapy (ciNPT) Dressing<br>Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit | Device: Closed Incision Negative Pressure Therapy (ciNPT)<br>* Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision<br>* Other names: Prevena Plus 125 Therapy Unit;|
| Active Comparator: Standard Silver-containing Dressing<br> | Device: Standard Silver-containing Dressing<br>* A standard silver-containing dressing applied to a closed surgical incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Lower Limb Volume | Percent change in lower limb volume as calculated using manual circumference measurements | 5-7 days after bilateral TKA procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Lower Limb Volume | Percent change in lower limb volume as calculated using manual circumference measurements | 12-14 days after bilateral TKA procedure | 
| Percent Change in Lower Limb Volume | Percent change in lower limb volume as calculated using manual circumference measurements | 35-49 days after bilateral TKA procedure | 
| Percent Change in Lower Limb Volume | Percent change in lower limb volume as calculated using manual circumference measurements | 77-91 days after bilateral TKA procedure | 
| Percent Change in Lower Limb Circumference | Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella, 10cm below the center of the patella and 1cm above medial malleolus of ankle | 5-7 days after bilateral TKA procedure | 
| Percent Change in Lower Limb Circumference | Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella, 10cm below the center of the patella and 1cm above medial malleolus of ankle | 12-14 days after bilateral TKA procedure | 
| Percent Change in Lower Limb Circumference | Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella, 10cm below the center of the patella and 1cm above medial malleolus of ankle | 35-49 days after bilateral TKA procedure | 
| Percent Change in Lower Limb Circumference | Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella, 10cm below the center of the patella and 1cm above medial malleolus of ankle | 77-91 days after bilateral TKA procedure | 
| Change in Knee Flexion Angle | Change in knee flexion angle | 5-7 days after bilateral TKA procedure | 
| Change in Knee Flexion Angle | Change in knee flexion angle | 12-14 days after bilateral TKA procedure | 
| Change in Knee Flexion Angle | Change in knee flexion angle | 35-49 days after bilateral TKA procedure | 
| Change in Knee Flexion Angle | Change in knee flexion angle | 77-91 days after bilateral TKA procedure | 
| Change in Knee Extension Angle | Change in knee extension angle | 5-7 days after bilateral TKA procedure | 
| Change in Knee Extension Angle | Change in knee extension angle | 12-14 days after bilateral TKA procedure | 
| Change in Knee Extension Angle | Change in knee extension angle | 35-49 days after bilateral TKA procedure | 
| Change in Knee Extension Angle | Change in knee extension angle | 77-91 days after bilateral TKA procedure | 
| Change of Total Range of Motion in Degrees | Change of total ROM degrees, defined as the flexion angle minus the extension angle | 5-7 days after bilateral TKA procedure | 
| Change of Total Range of Motion in Degrees | Change of total ROM degrees, defined as the flexion angle minus the extension angle | 12-14 days after bilateral TKA procedure | 
| Change of Total Range of Motion in Degrees | Change of total ROM degrees, defined as the flexion angle minus the extension angle | 35-49 days after bilateral TKA procedure | 
| Change of Total Range of Motion in Degrees | Change of total ROM degrees, defined as the flexion angle minus the extension angle | 77-91 days after bilateral TKA procedure | 
| Incidence of Surgical Site Complications (SSCs) | Incidence of surgical site complications defined as: Superficial Surgical Site Infection (SSI) Deep SSI Full thickness skin dehiscence Seroma or hematoma requiring drainage or surgery Skin necrosis Continued drainage at the time of dressing removal | within 49 days of bilateral TKA procedure | 
| Incidence of Surgical Site Complications (SSCs) | Incidence of surgical site complications defined as: Superficial Surgical Site Infection (SSI) Deep SSI Full thickness skin dehiscence Seroma or hematoma requiring drainage or surgery Skin necrosis Continued drainage at the time of dressing removal | within 91 days of bilateral TKA procedure | 
| Scar assessment | Evaluation of wound and scar using scar cosmesis assessment | 5-7 days after bilateral TKA procedure | 
| Scar assessment | Evaluation of wound and scar using scar cosmesis assessment | 12-14 days after bilateral TKA procedure | 
| Scar assessment | Evaluation of wound and scar using scar cosmesis assessment | 35-49 days after bilateral TKA procedure | 
| Scar assessment | Evaluation of wound and scar using scar cosmesis assessment | 77-91 days after bilateral TKA procedure | 
| Average pain rating on 0-10 scale | Average pain in each leg using NPRS rating scale | Daily for 4 weeks post-surgery, then weekly for weeks 5-12 | 
| Worst pain rating on 0-10 scale | Worst pain in last 24 hours for each leg using NPRS rating scale | Daily for 4 weeks post-surgery, then weekly for weeks 5-12 |