NCT04712019TerminatedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Solventum US LLC
- Enrollment
- 10
- Locations
- 11
- Primary Endpoint
- Percent Change in Lower Limb Volume
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change in Knee Flexion Angle(77-91 days after bilateral TKA procedure)
- Change in Knee Extension Angle(77-91 days after bilateral TKA procedure)
- Scar Cosmesis Assessment(Long Term Follow-up occurring 77-91 days after bilateral TKA procedure)
- Percent Change in Lower Limb Volume(77-91 days after bilateral TKA procedure)
- Percent Change in Lower Limb Circumference(77-91 days after bilateral TKA procedure)
- Change of Total Range of Motion in Degrees(77-91 days after bilateral TKA procedure)
- Incidence of Surgical Site Complications (SSCs)(within 91 days of bilateral TKA procedure)
- Average Pain in Each Leg in the Last 24 Hours(End of Treatment Visit occurring 12-14 days after bilateral TKA procedure)
- Worst Pain in Each Leg in the Last 24 Hours(End of Treatment Visit occurring 12-14 days after bilateral TKA procedure)
Investigators
Study Sites (11)
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