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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04712019




Registration number
NCT04712019
Ethics application status
Date submitted
14/01/2021
Date registered
15/01/2021
Date last updated
1/10/2024

Titles & IDs
Public title
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
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
Secondary ID [1] 0 0
PREVENA.RESTOR.ARTHRO.2019.01
Universal Trial Number (UTN)
Trial acronym
ENABLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 0 0 0 0
Other skin conditions
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change in Lower Limb Volume
Timepoint [1] 0 0
5-7 days after bilateral TKA procedure
Secondary outcome [1] 0 0
Percent Change in Lower Limb Volume
Timepoint [1] 0 0
12-14 days after bilateral TKA procedure
Secondary outcome [2] 0 0
Percent Change in Lower Limb Volume
Timepoint [2] 0 0
35-49 days after bilateral TKA procedure
Secondary outcome [3] 0 0
Percent Change in Lower Limb Volume
Timepoint [3] 0 0
77-91 days after bilateral TKA procedure
Secondary outcome [4] 0 0
Percent Change in Lower Limb Circumference
Timepoint [4] 0 0
5-7 days after bilateral TKA procedure
Secondary outcome [5] 0 0
Percent Change in Lower Limb Circumference
Timepoint [5] 0 0
12-14 days after bilateral TKA procedure
Secondary outcome [6] 0 0
Percent Change in Lower Limb Circumference
Timepoint [6] 0 0
35-49 days after bilateral TKA procedure
Secondary outcome [7] 0 0
Percent Change in Lower Limb Circumference
Timepoint [7] 0 0
77-91 days after bilateral TKA procedure
Secondary outcome [8] 0 0
Change in Knee Flexion Angle
Timepoint [8] 0 0
5-7 days after bilateral TKA procedure
Secondary outcome [9] 0 0
Change in Knee Flexion Angle
Timepoint [9] 0 0
12-14 days after bilateral TKA procedure
Secondary outcome [10] 0 0
Change in Knee Flexion Angle
Timepoint [10] 0 0
35-49 days after bilateral TKA procedure
Secondary outcome [11] 0 0
Change in Knee Flexion Angle
Timepoint [11] 0 0
77-91 days after bilateral TKA procedure
Secondary outcome [12] 0 0
Change in Knee Extension Angle
Timepoint [12] 0 0
5-7 days after bilateral TKA procedure
Secondary outcome [13] 0 0
Change in Knee Extension Angle
Timepoint [13] 0 0
12-14 days after bilateral TKA procedure
Secondary outcome [14] 0 0
Change in Knee Extension Angle
Timepoint [14] 0 0
35-49 days after bilateral TKA procedure
Secondary outcome [15] 0 0
Change in Knee Extension Angle
Timepoint [15] 0 0
77-91 days after bilateral TKA procedure
Secondary outcome [16] 0 0
Change of Total Range of Motion in Degrees
Timepoint [16] 0 0
5-7 days after bilateral TKA procedure
Secondary outcome [17] 0 0
Change of Total Range of Motion in Degrees
Timepoint [17] 0 0
12-14 days after bilateral TKA procedure
Secondary outcome [18] 0 0
Change of Total Range of Motion in Degrees
Timepoint [18] 0 0
35-49 days after bilateral TKA procedure
Secondary outcome [19] 0 0
Change of Total Range of Motion in Degrees
Timepoint [19] 0 0
77-91 days after bilateral TKA procedure
Secondary outcome [20] 0 0
Incidence of Surgical Site Complications (SSCs)
Timepoint [20] 0 0
within 49 days of bilateral TKA procedure
Secondary outcome [21] 0 0
Incidence of Surgical Site Complications (SSCs)
Timepoint [21] 0 0
within 91 days of bilateral TKA procedure
Secondary outcome [22] 0 0
Scar assessment
Timepoint [22] 0 0
5-7 days after bilateral TKA procedure
Secondary outcome [23] 0 0
Scar assessment
Timepoint [23] 0 0
12-14 days after bilateral TKA procedure
Secondary outcome [24] 0 0
Scar assessment
Timepoint [24] 0 0
35-49 days after bilateral TKA procedure
Secondary outcome [25] 0 0
Scar assessment
Timepoint [25] 0 0
77-91 days after bilateral TKA procedure
Secondary outcome [26] 0 0
Average pain rating on 0-10 scale
Timepoint [26] 0 0
Daily for 4 weeks post-surgery, then weekly for weeks 5-12
Secondary outcome [27] 0 0
Worst pain rating on 0-10 scale
Timepoint [27] 0 0
Daily for 4 weeks post-surgery, then weekly for weeks 5-12

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.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/08/2022
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
New York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Solventum US LLC
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04712019
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Fred Cushner, MD
Address 0 0
Hospital for Special Surgery, New York
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04712019