Clinical trial NCT04712019: Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Wound
Bilateral Total Knee Arthroplasty
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Edema Leg
Joint Pain
Arthritis Knee
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2021-01-15
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One leg receives ciNPT and the other leg receives standard silver containing dressing.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Lower Limb Volume
timeFrame: 5-7 days after bilateral TKA procedure
Secondary outcomes:
measure: Percent Change in Lower Limb Volume
timeFrame: 12-14 days after bilateral TKA procedure
measure: Percent Change in Lower Limb Volume
timeFrame: 35-49 days after bilateral TKA procedure
measure: Percent Change in Lower Limb Volume
timeFrame: 77-91 days after bilateral TKA procedure
measure: Percent Change in Lower Limb Circumference
timeFrame: 5-7 days after bilateral TKA procedure
measure: Percent Change in Lower Limb Circumference
timeFrame: 12-14 days after bilateral TKA procedure
measure: Percent Change in Lower Limb Circumference
timeFrame: 35-49 days after bilateral TKA procedure
measure: Percent Change in Lower Limb Circumference
timeFrame: 77-91 days after bilateral TKA procedure
measure: Change in Knee Flexion Angle
timeFrame: 5-7 days after bilateral TKA procedure
measure: Change in Knee Flexion Angle
timeFrame: 12-14 days after bilateral TKA procedure
measure: Change in Knee Flexion Angle
timeFrame: 35-49 days after bilateral TKA procedure
measure: Change in Knee Flexion Angle
timeFrame: 77-91 days after bilateral TKA procedure
measure: Change in Knee Extension Angle
timeFrame: 5-7 days after bilateral TKA procedure
measure: Change in Knee Extension Angle
timeFrame: 12-14 days after bilateral TKA procedure
measure: Change in Knee Extension Angle
timeFrame: 35-49 days after bilateral TKA procedure
measure: Change in Knee Extension Angle
timeFrame: 77-91 days after bilateral TKA procedure
measure: Change of Total Range of Motion in Degrees
timeFrame: 5-7 days after bilateral TKA procedure
measure: Change of Total Range of Motion in Degrees
timeFrame: 12-14 days after bilateral TKA procedure
measure: Change of Total Range of Motion in Degrees
timeFrame: 35-49 days after bilateral TKA procedure
measure: Change of Total Range of Motion in Degrees
timeFrame: 77-91 days after bilateral TKA procedure
measure: Incidence of Surgical Site Complications (SSCs)
timeFrame: within 49 days of bilateral TKA procedure
measure: Incidence of Surgical Site Complications (SSCs)
timeFrame: within 91 days of bilateral TKA procedure
measure: Scar Cosmesis Assessment
timeFrame: Long Term Follow-up occurring 77-91 days after bilateral TKA procedure
measure: Average Pain in Each Leg in the Last 24 Hours
timeFrame: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure
measure: Worst Pain in Each Leg in the Last 24 Hours
timeFrame: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure
Other outcomes:
Locations:
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Rubin Institute for Advanced Orthopedics
state: Maryland
city: Columbia
country: United States
facility: Johns Hopkins Orthopaedics
state: Maryland
city: Bay Shore
country: United States
facility: Northwell Health - Southside Hospital
state: New York
city: New York
country: United States
facility: Northwell Health - Lenox Hill Hospital
state: New York
city: Valley Stream
country: United States
facility: Northwell Health - Long Island Jewish Valley Stream
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Fred Cushner, MD
role: PRINCIPAL_INVESTIGATOR
References: