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Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA | Clinical Trials | Clareo Health

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

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

NCT04712019•Solventum US LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

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.
+11 more criteria

Locations (6)

Anne Arundel Medical Center

Annapolis, Maryland, United States

Rubin Institute for Advanced Orthopedics

Baltimore, Maryland, United States

Johns Hopkins Orthopaedics

Columbia, Maryland, United States

Northwell Health - Southside Hospital

Bay Shore, New York, United States

Northwell Health - Lenox Hill Hospital

New York, New York, United States

Northwell Health - Long Island Jewish Valley Stream

Valley Stream, New York, United States

Key Dates

Start Date

November 6, 2020

Primary Completion Date

August 26, 2022

Completion Date

August 26, 2022

Last Updated

October 1, 2024

Enrollment

ACTUAL participants

Conditions

Surgical WoundBilateral Total Knee ArthroplastyWounds and InjuriesJoint DiseasesMusculoskeletal DiseasesEdema LegJoint PainArthritis Knee

Interventions

Closed Incision Negative Pressure Therapy (ciNPT)

DEVICE

Standard Silver-containing Dressing

DEVICE

Machine Learning for Handheld Vascular Studies

NCT02932176

AtherosclerosisWounds and Injuries

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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