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

NCT04712019 | Terminated Results FDA Device

• 1 other identifier: PREVENA.RESTOR.ARTHRO.2019.01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Percent Change in Lower Limb Volume

  12-14 days after bilateral TKA procedure

• Percent Change in Lower Limb Volume

  35-49 days after bilateral TKA procedure

• Percent Change in Lower Limb Volume

  77-91 days after bilateral TKA procedure

• Percent Change in Lower Limb Circumference

  5-7 days after bilateral TKA procedure

• Percent Change in Lower Limb Circumference

  12-14 days after bilateral TKA procedure

Study Arms (2)

Closed Incision Negative Pressure Therapy (ciNPT) Dressing

EXPERIMENTAL

Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit

Device: Closed Incision Negative Pressure Therapy (ciNPT)

Standard Silver-containing Dressing

ACTIVE COMPARATOR

Standard silver dressing - standard of care at hospital

Device: Standard Silver-containing Dressing

Interventions

Closed Incision Negative Pressure Therapy (ciNPT) 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

Also known as: Prevena Restor ArthroForm, Prevena Plus 125 Therapy Unit

Closed Incision Negative Pressure Therapy (ciNPT) Dressing

Standard Silver-containing Dressing DEVICE

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

Standard Silver-containing Dressing

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (6)

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Rubin Institute for Advanced Orthopedics

Baltimore, Maryland, 21215, United States

Location

Johns Hopkins Orthopaedics

Columbia, Maryland, 21044, United States

Location

Northwell Health - Southside Hospital

Bay Shore, New York, 11706, United States

Location

Northwell Health - Lenox Hill Hospital

New York, New York, 10075, United States

Location

Northwell Health - Long Island Jewish Valley Stream

Valley Stream, New York, 11580, United States

Location

MeSH Terms

Conditions

Surgical Wound; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination of the study due to inability to enroll in the trial lead to a small number of subjects analyzed as well as incomplete data assessments.

Results Point of Contact

• Title: Biostatistics Manager
• Organization: 3M

swalters@mmm.com

651-382-2876

Study Officials

• Fred Cushner, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One leg receives ciNPT and the other leg receives standard silver containing dressing.

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 15, 2021
• Study Start: November 6, 2020
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: October 1, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)