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

November 7, 2022 updated by: 3M

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21215
        • Rubin Institute for Advanced Orthopedics
      • Columbia, Maryland, United States, 21044
        • Johns Hopkins Orthopaedics
    • New York
      • Bay Shore, New York, United States, 11706
        • Northwell Health - Southside Hospital
      • New York, New York, United States, 10075
        • Northwell Health - Lenox Hill Hospital
      • Valley Stream, New York, United States, 11580
        • Northwell Health - Long Island Jewish Valley Stream

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Closed Incision Negative Pressure Therapy (ciNPT) Dressing
Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit
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
Other Names:
  • Prevena Plus 125 Therapy Unit
  • Prevena Restor ArthroForm
ACTIVE_COMPARATOR: Standard Silver-containing Dressing
A standard silver-containing dressing applied to a closed surgical incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Lower Limb Volume
Time Frame: 5-7 days after bilateral TKA procedure
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
Time Frame: 12-14 days after bilateral TKA procedure
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
Time Frame: 35-49 days after bilateral TKA procedure
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
Time Frame: 77-91 days after bilateral TKA procedure
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
Time Frame: 5-7 days after bilateral TKA procedure
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
Time Frame: 12-14 days after bilateral TKA procedure
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
Time Frame: 35-49 days after bilateral TKA procedure
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
Time Frame: 77-91 days after bilateral TKA procedure
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
Time Frame: 5-7 days after bilateral TKA procedure
Change in knee flexion angle
5-7 days after bilateral TKA procedure
Change in Knee Flexion Angle
Time Frame: 12-14 days after bilateral TKA procedure
Change in knee flexion angle
12-14 days after bilateral TKA procedure
Change in Knee Flexion Angle
Time Frame: 35-49 days after bilateral TKA procedure
Change in knee flexion angle
35-49 days after bilateral TKA procedure
Change in Knee Flexion Angle
Time Frame: 77-91 days after bilateral TKA procedure
Change in knee flexion angle
77-91 days after bilateral TKA procedure
Change in Knee Extension Angle
Time Frame: 5-7 days after bilateral TKA procedure
Change in knee extension angle
5-7 days after bilateral TKA procedure
Change in Knee Extension Angle
Time Frame: 12-14 days after bilateral TKA procedure
Change in knee extension angle
12-14 days after bilateral TKA procedure
Change in Knee Extension Angle
Time Frame: 35-49 days after bilateral TKA procedure
Change in knee extension angle
35-49 days after bilateral TKA procedure
Change in Knee Extension Angle
Time Frame: 77-91 days after bilateral TKA procedure
Change in knee extension angle
77-91 days after bilateral TKA procedure
Change of Total Range of Motion in Degrees
Time Frame: 5-7 days after bilateral TKA procedure
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
Time Frame: 12-14 days after bilateral TKA procedure
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
Time Frame: 35-49 days after bilateral TKA procedure
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
Time Frame: 77-91 days after bilateral TKA procedure
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)
Time Frame: within 49 days of bilateral TKA procedure

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)
Time Frame: within 91 days of bilateral TKA procedure

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
Time Frame: 5-7 days after bilateral TKA procedure
Evaluation of wound and scar using scar cosmesis assessment
5-7 days after bilateral TKA procedure
Scar assessment
Time Frame: 12-14 days after bilateral TKA procedure
Evaluation of wound and scar using scar cosmesis assessment
12-14 days after bilateral TKA procedure
Scar assessment
Time Frame: 35-49 days after bilateral TKA procedure
Evaluation of wound and scar using scar cosmesis assessment
35-49 days after bilateral TKA procedure
Scar assessment
Time Frame: 77-91 days after bilateral TKA procedure
Evaluation of wound and scar using scar cosmesis assessment
77-91 days after bilateral TKA procedure
Average pain rating on 0-10 scale
Time Frame: Daily for 4 weeks post-surgery, then weekly for weeks 5-12
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
Time Frame: Daily for 4 weeks post-surgery, then weekly for weeks 5-12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3M

Investigators

  • Principal Investigator: Fred Cushner, MD, Hospital for Special Surgery, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2020

Primary Completion (ACTUAL)

August 26, 2022

Study Completion (ACTUAL)

August 26, 2022

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (ACTUAL)

January 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PREVENA.RESTOR.ARTHRO.2019.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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