Total Hip Arthroplasty
Conditions
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.
Interventions
DEVICEActiveCare+SFT Supine
DEVICEVenaFlow Elite Supine
DEVICEActiveCare+SFT Standing
DEVICEVenaFlow Elite Standing
Sponsors
DJO Incorporated
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 10 Healthy Patients Without THA 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.
ActiveCare+SFT Supine
VenaFlow Elite Supine
ActiveCare+SFT Standing
VenaFlow Elite Standing | 10 |
| 10 Patients With THA on Post-Op Day 2 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.
ActiveCare+SFT Supine
VenaFlow Elite Supine
ActiveCare+SFT Standing
VenaFlow Elite Standing | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | 10 Patients With THA on Post-Op Day 2 | 10 Healthy Patients Without THA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 0 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 10 Participants | 15 Participants |
| Age, Continuous | 64.6 years | 28.7 years | 46.65 years |
| Region of Enrollment United States | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Peak Venous Velocity
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.
Time frame: Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 10 Healthy Patients Without THA | Peak Venous Velocity | delta PVV from before to after Activecare (supine) | 40.5 cm/s |
| 10 Healthy Patients Without THA | Peak Venous Velocity | Delta PVV from before to after Venaflow (Supine) | 87.1 cm/s |
| 10 Healthy Patients Without THA | Peak Venous Velocity | Delta PVV from before to after Venaflow (Standing) | 127.9 cm/s |
| 10 Healthy Patients Without THA | Peak Venous Velocity | delta PVV from before to after Activeca (Standing) | 32.6 cm/s |
| 10 Patients With THA on Post-Op Day 2 | Peak Venous Velocity | Delta PVV from before to after Venaflow (Standing) | 155.7 cm/s |
| 10 Patients With THA on Post-Op Day 2 | Peak Venous Velocity | delta PVV from before to after Activecare (supine) | 37.8 cm/s |
| 10 Patients With THA on Post-Op Day 2 | Peak Venous Velocity | delta PVV from before to after Activeca (Standing) | 41.9 cm/s |
| 10 Patients With THA on Post-Op Day 2 | Peak Venous Velocity | Delta PVV from before to after Venaflow (Supine) | 86.8 cm/s |