A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Total Hip Arthroplasty

Treatments: Device: VenaFlow Elite Supine; Device: ActiveCare+SFT Standing; Device: ActiveCare+SFT Supine; Device: VenaFlow Elite Standing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02345642

14064

Details and patient eligibility

About

We are comparing two pneumatic compression devices, VenaFlow (stationary) and MCS (portable) in both the supine an standing position. We will start supine and will take 3 baseline measurements of venous velocity and then apply a device and take 3 measurements of the increase in peak venous velocity. We will repeat this with the second device. We will then have the subject stand and repeat the above with each device. We will randomize the order of the devices in the supine and standing position. This study will involve 10 healthy subjects of various ages and 10 total hip replacements (THR) patients.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Phase one: 10 healthy test subjects will be included of various ages. They will have each pneumatic compression device applied in the supine and then standing positions.

Phase two: 10 patients following THR on postoperative day #2 will be included. These patients will agree to participate in the study and have to be able to stand for approximately 10 minutes.

Exclusion criteria

• Patients with lymphedema
• Patients with peripheral vascular disease (chronic venous insufficiency)
• Patients who do not wish to participate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

10 Healthy Patients without THA

Active Comparator group

Description:

The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.

Treatment:

Device: VenaFlow Elite Standing

Device: ActiveCare+SFT Supine

Device: ActiveCare+SFT Standing

Device: VenaFlow Elite Supine

10 Patients with THA on Post-Op Day 2

Experimental group

Description:

The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.

Treatment:

Device: VenaFlow Elite Standing

Device: ActiveCare+SFT Supine

Device: ActiveCare+SFT Standing

Device: VenaFlow Elite Supine