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

September 27, 2024 updated by: Solventum US LLC

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Closed Incision Negative Pressure Therapy (ciNPT) Dressing
Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit
Device: Closed Incision Negative Pressure Therapy (ciNPT)
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
Standard silver dressing - standard of care at hospital
Device: Standard Silver-containing Dressing
A standard silver-containing dressing applied to a closed surgical incision

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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 and 10cm below the center of the patella
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 and 10cm below the center of the patella
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 and 10cm below the center of the patella
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 and 10cm below the center of the patella
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 from baseline to Visit 3
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 from baseline to Visit 4
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 from baseline to Visit 5
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 from baseline to Visit 6
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 from baseline to Visit 3
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 from baseline to Visit 4
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 from baseline to Visit 5
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 from baseline to Visit 6
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 from baseline to Visit 3
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 from baseline to Visit 4
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 from baseline to Visit 5
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 from baseline to Visit 6
77-91 days after bilateral TKA procedure
Scar Cosmesis Assessment
Time Frame: Long Term Follow-up occurring 77-91 days after bilateral TKA procedure
Validated tool to assess the quality of postoperative scars in clinical and research settings. Scores range from 4 (best) to 14 (worst). Due to the lack of subjects and study data, only the value recorded at the final study visit was analyzed for each subject. The average score for each study arm was then calculated with the available data.
Long Term Follow-up occurring 77-91 days after bilateral TKA procedure
Average Pain in Each Leg in the Last 24 Hours
Time Frame: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure
The average pain in each leg in the last 24 hours, using an NPRS (numerical pain rating scale) of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data.
End of Treatment Visit occurring 12-14 days after bilateral TKA procedure
Worst Pain in Each Leg in the Last 24 Hours
Time Frame: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure
The worst pain in each leg in the last 24 hours, using an NPRS of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data.
End of Treatment Visit occurring 12-14 days after bilateral TKA procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Solventum US LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
3M

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

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