A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices

Not Applicable

Completed

Conditions: Total Hip Arthroplasty

Interventions: Device: ActiveCare+SFT Supine
Device: VenaFlow Elite Supine
Device: ActiveCare+SFT Standing
Device: VenaFlow Elite Standing

Registration Number: NCT02345642

Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 Patients with THA on Post-Op Day 2	ActiveCare+SFT Supine	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.
10 Healthy Patients without THA	ActiveCare+SFT Supine	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.
10 Healthy Patients without THA	VenaFlow Elite Supine	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.
10 Healthy Patients without THA	ActiveCare+SFT Standing	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.
10 Patients with THA on Post-Op Day 2	VenaFlow Elite Standing	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.
10 Patients with THA on Post-Op Day 2	VenaFlow Elite Supine	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.
10 Healthy Patients without THA	VenaFlow Elite Standing	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.
10 Patients with THA on Post-Op Day 2	ActiveCare+SFT Standing	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.

Primary Outcome Measures

Name	Time	Method
Peak Venous Velocity	Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied	Ultrasound of the venous system just below the saphenofemoral junction to assess the venous velocity will be taken before and after application the VenaFlow and the ActiveCare+S.F.T pneumatic compression devices. Change from Baseline in Peak Venous Velocity 30 minutes after Device is applied is recorded.

Secondary Outcome Measures