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

NCT ID: NCT04712019

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-06
• Study Completion Date: 2022-08-26

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Closed Incision Negative Pressure Therapy (ciNPT) Dressing

Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit

Group Type: EXPERIMENTAL

Closed Incision Negative Pressure Therapy (ciNPT)

Intervention Type: DEVICE

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

Standard silver dressing - standard of care at hospital

Group Type: ACTIVE_COMPARATOR

Standard Silver-containing Dressing

Intervention Type: DEVICE

A standard silver-containing dressing applied to a closed surgical incision

Interventions

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

Intervention Type: DEVICE

Standard Silver-containing Dressing

A standard silver-containing dressing applied to a closed surgical incision

Intervention Type: DEVICE

Other Intervention Names

Prevena Restor ArthroForm; Prevena Plus 125 Therapy Unit

Eligibility Criteria

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.

• 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

Solventum US LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fred Cushner, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PREVENA.RESTOR.ARTHRO.2019.01

Identifier Type: -

Identifier Source: org_study_id