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

N/ATerminatedNCT04712019

Solventum US LLC10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Surgical Wound Bilateral Total Knee Arthroplasty Wounds and Injuries Joint Diseases Musculoskeletal Diseases Edema Leg

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (6)

Anne Arundel Medical Center

Annapolis, Maryland, United States

Rubin Institute for Advanced Orthopedics

Baltimore, Maryland, United States

Johns Hopkins Orthopaedics

Columbia, Maryland, United States

Northwell Health - Southside Hospital

Bay Shore, New York, 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

Outcomes

Primary Outcomes

Percent Change in Lower Limb Volume

Percent change in lower limb volume as calculated using manual circumference measurements

Time frame: 5-7 days after bilateral TKA procedure

Secondary Outcomes

Percent Change in Lower Limb Volume

Percent change in lower limb volume as calculated using manual circumference measurements

Time frame: 12-14 days after bilateral TKA procedure

Percent Change in Lower Limb Volume

Percent change in lower limb volume as calculated using manual circumference measurements

Time frame: 35-49 days after bilateral TKA procedure

Percent Change in Lower Limb Volume

Percent change in lower limb volume as calculated using manual circumference measurements

Time frame: 77-91 days after bilateral TKA procedure

Percent Change in Lower Limb Circumference

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

Time frame: 5-7 days after bilateral TKA procedure

Percent Change in Lower Limb Circumference

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

Time frame: 12-14 days after bilateral TKA procedure

Percent Change in Lower Limb Circumference

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

Time frame: 35-49 days after bilateral TKA procedure

Percent Change in Lower Limb Circumference

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

Time frame: 77-91 days after bilateral TKA procedure

Change in Knee Flexion Angle

Change in knee flexion angle from baseline to Visit 3

Time frame: 5-7 days after bilateral TKA procedure

Change in Knee Flexion Angle

Change in knee flexion angle from baseline to Visit 4

Time frame: 12-14 days after bilateral TKA procedure

Change in Knee Flexion Angle

Change in knee flexion angle from baseline to Visit 5

Time frame: 35-49 days after bilateral TKA procedure

Change in Knee Flexion Angle

Change in knee flexion angle from baseline to Visit 6

Time frame: 77-91 days after bilateral TKA procedure

Change in Knee Extension Angle

Change in knee extension angle from baseline to Visit 3

Time frame: 5-7 days after bilateral TKA procedure

Change in Knee Extension Angle

Change in knee extension angle from baseline to Visit 4

Time frame: 12-14 days after bilateral TKA procedure

Change in Knee Extension Angle

Change in knee extension angle from baseline to Visit 5

Time frame: 35-49 days after bilateral TKA procedure

Change in Knee Extension Angle

Change in knee extension angle from baseline to Visit 6

Time frame: 77-91 days after bilateral TKA procedure

Change of Total Range of Motion in Degrees

Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 3

Time frame: 5-7 days after bilateral TKA procedure

Change of Total Range of Motion in Degrees

Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 4

Time frame: 12-14 days after bilateral TKA procedure

Change of Total Range of Motion in Degrees

Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 5

Time frame: 35-49 days after bilateral TKA procedure

Change of Total Range of Motion in Degrees

Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 6

Time frame: 77-91 days after bilateral TKA procedure

Incidence of Surgical Site Complications (SSCs)

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

Time frame: within 49 days of bilateral TKA procedure

Incidence of Surgical Site Complications (SSCs)

Time frame: within 91 days of bilateral TKA procedure

Scar Cosmesis Assessment

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.

Time frame: Long Term Follow-up occurring 77-91 days after bilateral TKA procedure

Average Pain in Each Leg in the Last 24 Hours

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.

Time frame: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure

Worst Pain in Each Leg in the Last 24 Hours

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.

Time frame: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes