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

Not Applicable

Terminated

Conditions: Musculoskeletal Diseases
Edema Leg
Arthritis Knee
Surgical Wound
Bilateral Total Knee Arthroplasty
Joint Pain
Wounds and Injuries
Joint Diseases

Interventions: Device: Closed Incision Negative Pressure Therapy (ciNPT)
Device: Standard Silver-containing Dressing

Registration Number: NCT04712019

Lead Sponsor: Solventum US LLC

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Closed Incision Negative Pressure Therapy (ciNPT) Dressing	Closed Incision Negative Pressure Therapy (ciNPT)	Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit
Standard Silver-containing Dressing	Standard Silver-containing Dressing	Standard silver dressing - standard of care at hospital

Primary Outcome Measures

Name	Time	Method
Percent Change in Lower Limb Volume	5-7 days after bilateral TKA procedure	Percent change in lower limb volume as calculated using manual circumference measurements

Secondary Outcome Measures

Name	Time	Method
Change in Knee Extension Angle	77-91 days after bilateral TKA procedure	Change in knee extension angle from baseline to Visit 6
Scar Cosmesis Assessment	Long Term Follow-up occurring 77-91 days after bilateral TKA procedure	Validated tool to assess the quality of postoperative scars in clinical and research settings. Scores range from 4 (best) to 14 (worst). Due to the lack of subjects and study data, only the value recorded at the final study visit was analyzed for each subject. The average score for each study arm was then calculated with the available data.
Percent Change in Lower Limb Volume	77-91 days after bilateral TKA procedure	Percent change in lower limb volume as calculated using manual circumference measurements
Percent Change in Lower Limb Circumference	77-91 days after bilateral TKA procedure	Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella
Change in Knee Flexion Angle	77-91 days after bilateral TKA procedure	Change in knee flexion angle from baseline to Visit 6
Change of Total Range of Motion in Degrees	77-91 days after bilateral TKA procedure	Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 6
Incidence of Surgical Site Complications (SSCs)	within 91 days of bilateral TKA procedure	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
Average Pain in Each Leg in the Last 24 Hours	End of Treatment Visit occurring 12-14 days after bilateral TKA procedure	The average pain in each leg in the last 24 hours, using an NPRS (numerical pain rating scale) of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data.
Worst Pain in Each Leg in the Last 24 Hours	End of Treatment Visit occurring 12-14 days after bilateral TKA procedure	The worst pain in each leg in the last 24 hours, using an NPRS of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data.

Trial Locations

Locations (6): Northwell Health - Southside Hospital
🇺🇸
Bay Shore, New York, United States
Rubin Institute for Advanced Orthopedics
🇺🇸
Baltimore, Maryland, United States
Anne Arundel Medical Center
🇺🇸
Annapolis, Maryland, United States
Johns Hopkins Orthopaedics
🇺🇸
Columbia, Maryland, United States
Northwell Health - Lenox Hill Hospital
🇺🇸
New York, New York, United States
Northwell Health - Long Island Jewish Valley Stream
🇺🇸
Valley Stream, New York, United States