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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04712019
Registration number
NCT04712019
Ethics application status
Date submitted
14/01/2021
Date registered
15/01/2021
Date last updated
8/11/2022
Titles & IDs
Public title
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
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Scientific title
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
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Secondary ID [1]
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PREVENA.RESTOR.ARTHRO.2019.01
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Universal Trial Number (UTN)
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Trial acronym
ENABLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Skin
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Other skin conditions
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Surgery
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Closed Incision Negative Pressure Therapy (ciNPT)
Treatment: Devices - Standard Silver-containing Dressing
Experimental: Closed Incision Negative Pressure Therapy (ciNPT) Dressing - Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit
Active Comparator: Standard Silver-containing Dressing -
Treatment: Devices: 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
Treatment: Devices: Standard Silver-containing Dressing
A standard silver-containing dressing applied to a closed surgical incision
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change in Lower Limb Volume
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Assessment method [1]
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Percent change in lower limb volume as calculated using manual circumference measurements
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Timepoint [1]
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5-7 days after bilateral TKA procedure
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Secondary outcome [1]
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Percent Change in Lower Limb Volume
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Assessment method [1]
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Percent change in lower limb volume as calculated using manual circumference measurements
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Timepoint [1]
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12-14 days after bilateral TKA procedure
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Secondary outcome [2]
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Percent Change in Lower Limb Volume
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Assessment method [2]
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Percent change in lower limb volume as calculated using manual circumference measurements
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Timepoint [2]
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35-49 days after bilateral TKA procedure
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Secondary outcome [3]
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Percent Change in Lower Limb Volume
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Assessment method [3]
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Percent change in lower limb volume as calculated using manual circumference measurements
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Timepoint [3]
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77-91 days after bilateral TKA procedure
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Secondary outcome [4]
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Percent Change in Lower Limb Circumference
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Assessment method [4]
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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
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Timepoint [4]
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5-7 days after bilateral TKA procedure
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Secondary outcome [5]
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Percent Change in Lower Limb Circumference
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Assessment method [5]
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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
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Timepoint [5]
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12-14 days after bilateral TKA procedure
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Secondary outcome [6]
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Percent Change in Lower Limb Circumference
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Assessment method [6]
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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
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Timepoint [6]
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35-49 days after bilateral TKA procedure
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Secondary outcome [7]
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Percent Change in Lower Limb Circumference
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Assessment method [7]
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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
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Timepoint [7]
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77-91 days after bilateral TKA procedure
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Secondary outcome [8]
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Change in Knee Flexion Angle
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Assessment method [8]
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Change in knee flexion angle
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Timepoint [8]
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5-7 days after bilateral TKA procedure
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Secondary outcome [9]
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Change in Knee Flexion Angle
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Assessment method [9]
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Change in knee flexion angle
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Timepoint [9]
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12-14 days after bilateral TKA procedure
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Secondary outcome [10]
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Change in Knee Flexion Angle
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Assessment method [10]
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Change in knee flexion angle
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Timepoint [10]
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35-49 days after bilateral TKA procedure
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Secondary outcome [11]
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Change in Knee Flexion Angle
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Assessment method [11]
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Change in knee flexion angle
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Timepoint [11]
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77-91 days after bilateral TKA procedure
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Secondary outcome [12]
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Change in Knee Extension Angle
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Assessment method [12]
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Change in knee extension angle
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Timepoint [12]
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5-7 days after bilateral TKA procedure
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Secondary outcome [13]
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Change in Knee Extension Angle
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Assessment method [13]
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Change in knee extension angle
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Timepoint [13]
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12-14 days after bilateral TKA procedure
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Secondary outcome [14]
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Change in Knee Extension Angle
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Assessment method [14]
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Change in knee extension angle
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Timepoint [14]
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35-49 days after bilateral TKA procedure
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Secondary outcome [15]
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Change in Knee Extension Angle
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Assessment method [15]
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Change in knee extension angle
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Timepoint [15]
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77-91 days after bilateral TKA procedure
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Secondary outcome [16]
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Change of Total Range of Motion in Degrees
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Assessment method [16]
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Change of total ROM degrees, defined as the flexion angle minus the extension angle
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Timepoint [16]
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5-7 days after bilateral TKA procedure
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Secondary outcome [17]
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Change of Total Range of Motion in Degrees
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Assessment method [17]
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Change of total ROM degrees, defined as the flexion angle minus the extension angle
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Timepoint [17]
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12-14 days after bilateral TKA procedure
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Secondary outcome [18]
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Change of Total Range of Motion in Degrees
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Assessment method [18]
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Change of total ROM degrees, defined as the flexion angle minus the extension angle
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Timepoint [18]
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35-49 days after bilateral TKA procedure
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Secondary outcome [19]
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Change of Total Range of Motion in Degrees
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Assessment method [19]
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Change of total ROM degrees, defined as the flexion angle minus the extension angle
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Timepoint [19]
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77-91 days after bilateral TKA procedure
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Secondary outcome [20]
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Incidence of Surgical Site Complications (SSCs)
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Assessment method [20]
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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
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Timepoint [20]
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within 49 days of bilateral TKA procedure
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Secondary outcome [21]
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Incidence of Surgical Site Complications (SSCs)
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Assessment method [21]
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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
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Timepoint [21]
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within 91 days of bilateral TKA procedure
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Secondary outcome [22]
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Scar assessment
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Assessment method [22]
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Evaluation of wound and scar using scar cosmesis assessment
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Timepoint [22]
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5-7 days after bilateral TKA procedure
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Secondary outcome [23]
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Scar assessment
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Assessment method [23]
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Evaluation of wound and scar using scar cosmesis assessment
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Timepoint [23]
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12-14 days after bilateral TKA procedure
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Secondary outcome [24]
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Scar assessment
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Assessment method [24]
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Evaluation of wound and scar using scar cosmesis assessment
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Timepoint [24]
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35-49 days after bilateral TKA procedure
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Secondary outcome [25]
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Scar assessment
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Assessment method [25]
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Evaluation of wound and scar using scar cosmesis assessment
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Timepoint [25]
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77-91 days after bilateral TKA procedure
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Secondary outcome [26]
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Average pain rating on 0-10 scale
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Assessment method [26]
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Average pain in each leg using NPRS rating scale
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Timepoint [26]
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Daily for 4 weeks post-surgery, then weekly for weeks 5-12
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Secondary outcome [27]
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Worst pain rating on 0-10 scale
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Assessment method [27]
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Worst pain in last 24 hours for each leg using NPRS rating scale
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Timepoint [27]
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Daily for 4 weeks post-surgery, then weekly for weeks 5-12
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Eligibility
Key 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.
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Minimum age
22
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/08/2022
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Sample size
Target
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Maryland
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Country [2]
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United States of America
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State/province [2]
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New York
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
3M
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04712019
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Fred Cushner, MD
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Address
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Hospital for Special Surgery, New York
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT04712019
Download to PDF