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

Solventum US LLC

Status

Terminated

Conditions

Arthritis Knee

Joint Diseases

Bilateral Total Knee Arthroplasty

Surgical Wound

Joint Pain

Musculoskeletal Diseases

Edema Leg

Wounds and Injuries

Treatments

Device: Standard Silver-containing Dressing

Device: Closed Incision Negative Pressure Therapy (ciNPT)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04712019

PREVENA.RESTOR.ARTHRO.2019.01

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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