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

Wounds and Injuries Clinical Trial

— ENABLE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04712019
• Other study ID #: PREVENA.RESTOR.ARTHRO.2019.01
• Status: Terminated
• Phase: N/A
• Start date: November 6, 2020
• Est. completion date: August 26, 2022

Study information

• Verified date: January 2024
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 26, 2022
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Closed Incision Negative Pressure Therapy (ciNPT)
Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision
• Standard Silver-containing Dressing
A standard silver-containing dressing applied to a closed surgical incision

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Rubin Institute for Advanced Orthopedics	Baltimore	Maryland
United States	Northwell Health - Southside Hospital	Bay Shore	New York
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

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Lower Limb Volume	Percent change in lower limb volume as calculated using manual circumference measurements	5-7 days after bilateral TKA procedure
Secondary	Percent Change in Lower Limb Volume	Percent change in lower limb volume as calculated using manual circumference measurements	12-14 days after bilateral TKA procedure
Secondary	Percent Change in Lower Limb Volume	Percent change in lower limb volume as calculated using manual circumference measurements	35-49 days after bilateral TKA procedure
Secondary	Percent Change in Lower Limb Volume	Percent change in lower limb volume as calculated using manual circumference measurements	77-91 days after bilateral TKA procedure
Secondary	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	5-7 days after bilateral TKA procedure
Secondary	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	12-14 days after bilateral TKA procedure
Secondary	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	35-49 days after bilateral TKA procedure
Secondary	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	77-91 days after bilateral TKA procedure
Secondary	Change in Knee Flexion Angle	Change in knee flexion angle from baseline to Visit 3	5-7 days after bilateral TKA procedure
Secondary	Change in Knee Flexion Angle	Change in knee flexion angle from baseline to Visit 4	12-14 days after bilateral TKA procedure
Secondary	Change in Knee Flexion Angle	Change in knee flexion angle from baseline to Visit 5	35-49 days after bilateral TKA procedure
Secondary	Change in Knee Flexion Angle	Change in knee flexion angle from baseline to Visit 6	77-91 days after bilateral TKA procedure
Secondary	Change in Knee Extension Angle	Change in knee extension angle from baseline to Visit 3	5-7 days after bilateral TKA procedure
Secondary	Change in Knee Extension Angle	Change in knee extension angle from baseline to Visit 4	12-14 days after bilateral TKA procedure
Secondary	Change in Knee Extension Angle	Change in knee extension angle from baseline to Visit 5	35-49 days after bilateral TKA procedure
Secondary	Change in Knee Extension Angle	Change in knee extension angle from baseline to Visit 6	77-91 days after bilateral TKA procedure
Secondary	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	5-7 days after bilateral TKA procedure
Secondary	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	12-14 days after bilateral TKA procedure
Secondary	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	35-49 days after bilateral TKA procedure
Secondary	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	77-91 days after bilateral TKA procedure
Secondary	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	within 49 days of bilateral TKA procedure
Secondary	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	within 91 days of bilateral TKA procedure
Secondary	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.	Long Term Follow-up occurring 77-91 days after bilateral TKA procedure
Secondary	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.	End of Treatment Visit occurring 12-14 days after bilateral TKA procedure
Secondary	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.	End of Treatment Visit occurring 12-14 days after bilateral TKA procedure