Total Hip ArthroplastyNCT02345642

A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices

A study testing ActiveCare+SFT Supine, VenaFlow Elite Supine and ActiveCare+SFT Standing in people with Total Hip Arthroplasty, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Total Hip Arthroplasty
What is being tested?: ActiveCare+SFT Supine, VenaFlow Elite Supine and ActiveCare+SFT Standing
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Jan 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

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.

Conditions: Total Hip Arthroplasty
Being tested: ActiveCare+SFT Supine, VenaFlow Elite Supine, ActiveCare+SFT Standing, VenaFlow Elite Standing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ActiveCare+SFT SupineDevice
Also called Portable Pneumatic Compression Device Supine
VenaFlow Elite SupineDevice
Also called Stationary Pneumatic Compression Device Supine
ActiveCare+SFT StandingDevice
Also called Portable Pneumatic Compression Device Standing
VenaFlow Elite StandingDevice
Also called Stationary Pneumatic Compression Device Standing

Study groups in NCT02345642
Study group	Role	What they receive
10 Healthy Patients without THA	Active comparator	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. Receives: Device: ActiveCare+SFT Supine; Device: VenaFlow Elite Supine; Device: ActiveCare+SFT Standing; Device: VenaFlow Elite Standing
10 Patients with THA on Post-Op Day 2	Experimental	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. Receives: Device: ActiveCare+SFT Supine; Device: VenaFlow Elite Supine; Device: ActiveCare+SFT Standing; Device: VenaFlow Elite Standing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Jan 2016

First posted26 Jan 2015 (estimated)
Study startFeb 2015
Primary completionJun 2015
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02345642
Sponsor's protocol ID: 14064
Status last verified: Sep 2017
First submitted: 20 Jan 2015
Last updated: 16 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Westrich GH, Specht LM, Sharrock NE, Windsor RE, Sculco TP, Haas SB, Trombley JF, Peterson M. Venous haemodynamics after total knee arthroplasty: evaluation of active dorsal to plantar flexion and several mechanical compression devices. J Bone Joint Surg Br. 1998 Nov;80(6):1057-66. doi: 10.1302/0301-620x.80b6.8627.
PubMed 9853503
Westrich GH, Specht LM, Sharrock NE, Sculco TP, Salvati EA, Pellicci PM, Trombley JF, Peterson M. Pneumatic compression hemodynamics in total hip arthroplasty. Clin Orthop Relat Res. 2000 Mar;(372):180-91. doi: 10.1097/00003086-200003000-00020.
PubMed 10738427
Johanson NA, Lachiewicz PF, Lieberman JR, Lotke PA, Parvizi J, Pellegrini V, Stringer TA, Tornetta P 3rd, Haralson RH 3rd, Watters WC 3rd. Prevention of symptomatic pulmonary embolism in patients undergoing total hip or knee arthroplasty. J Am Acad Orthop Surg. 2009 Mar;17(3):183-96. doi: 10.5435/00124635-200903000-00007.
PubMed 19264711
Pitto RP, Hamer H, Heiss-Dunlop W, Kuehle J. Mechanical prophylaxis of deep-vein thrombosis after total hip replacement a randomised clinical trial. J Bone Joint Surg Br. 2004 Jul;86(5):639-42. doi: 10.1302/0301-620x.86b5.14763.
PubMed 15274256
Ben-Galim P, Steinberg EL, Rosenblatt Y, Parnes N, Menahem A, Arbel R. A miniature and mobile intermittent pneumatic compression device for the prevention of deep-vein thrombosis after joint replacement. Acta Orthop Scand. 2004 Oct;75(5):584-7. doi: 10.1080/00016470410001466.
PubMed 15513491
Froimson MI, Murray TG, Fazekas AF. Venous thromboembolic disease reduction with a portable pneumatic compression device. J Arthroplasty. 2009 Feb;24(2):310-6. doi: 10.1016/j.arth.2007.10.030. Epub 2008 Apr 8.
PubMed 18534456
Murakami M, McDill TL, Cindrick-Pounds L, Loran DB, Woodside KJ, Mileski WJ, Hunter GC, Killewich LA. Deep venous thrombosis prophylaxis in trauma: improved compliance with a novel miniaturized pneumatic compression device. J Vasc Surg. 2003 Nov;38(5):923-7. doi: 10.1016/s0741-5214(03)00792-4.
PubMed 14603195
Colwell CW Jr, Spiro TE, Trowbridge AA, Morris BA, Kwaan HC, Blaha JD, Comerota AJ, Skoutakis VA. Use of enoxaparin, a low-molecular-weight heparin, and unfractionated heparin for the prevention of deep venous thrombosis after elective hip replacement. A clinical trial comparing efficacy and safety. Enoxaparin Clinical Trial Group. J Bone Joint Surg Am. 1994 Jan;76(1):3-14. doi: 10.2106/00004623-199401000-00002.
PubMed 8288662
Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.
PubMed 18574271
Silbersack Y, Taute BM, Hein W, Podhaisky H. Prevention of deep-vein thrombosis after total hip and knee replacement. Low-molecular-weight heparin in combination with intermittent pneumatic compression. J Bone Joint Surg Br. 2004 Aug;86(6):809-12. doi: 10.1302/0301-620x.86b6.13958.
PubMed 15330019
Edwards JZ, Pulido PA, Ezzet KA, Copp SN, Walker RH, Colwell CW Jr. Portable compression device and low-molecular-weight heparin compared with low-molecular-weight heparin for thromboprophylaxis after total joint arthroplasty. J Arthroplasty. 2008 Dec;23(8):1122-7. doi: 10.1016/j.arth.2007.11.006. Epub 2008 Apr 2.
PubMed 18534421

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
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Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)

All Total Hip Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices
ClinicalTrials.gov ID: NCT02345642
Acronym / sponsor ID: 14064
Conditions: Total Hip Arthroplasty
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Collaborators: DJO Incorporated
Study start: Feb 2015
Primary completion: Jun 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 26 Jan 2015 (estimated)
Results: Posted 16 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
10 Healthy Patients without THA	Active comparator	Device: ActiveCare+SFT Supine, Device: VenaFlow Elite Supine, Device: ActiveCare+SFT Standing, Device: VenaFlow Elite StandingThe 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	Experimental	Device: ActiveCare+SFT Supine, Device: VenaFlow Elite Supine, Device: ActiveCare+SFT Standing, Device: VenaFlow Elite StandingThe 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ActiveCare+SFT SupineAlso: Portable Pneumatic Compression Device Supine	Device	10 Healthy Patients without THA, 10 Patients with THA on Post-Op Day 2
VenaFlow Elite SupineAlso: Stationary Pneumatic Compression Device Supine	Device	10 Healthy Patients without THA, 10 Patients with THA on Post-Op Day 2
ActiveCare+SFT StandingAlso: Portable Pneumatic Compression Device Standing	Device	10 Healthy Patients without THA, 10 Patients with THA on Post-Op Day 2
VenaFlow Elite StandingAlso: Stationary Pneumatic Compression Device Standing	Device	10 Healthy Patients without THA, 10 Patients with THA on Post-Op Day 2

Primary outcome

Peak Venous Velocity
Time frame: 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.

Results and safety

Results posted to the registry on 16 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
10 Healthy Patients Without THA	10	10
10 Patients With THA on Post-Op Day 2	10	10

Primary outcome: Peak Venous Velocity

Time frame: Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied. Mean (Full Range). Unit: cm/s

Measure	10 Healthy Patients Without THA n = 10	10 Patients With THA on Post-Op Day 2 n = 10
Delta PVV from before to after Venaflow (Standing)	127.9 (40 to 188)	155.7 (106 to 270)
Delta PVV from before to after Venaflow (Supine)	87.1 (51 to 204)	86.8 (26 to 165)
delta PVV from before to after Activeca (Standing)	32.6 (16 to 44)	41.9 (11 to 85)
delta PVV from before to after Activecare (supine)	40.5 (9 to 66)	37.8 (28 to 51)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 Healthy Patients Without THA	0 of 10 (0%)	0 of 10 (0%)	0 of 10
10 Patients With THA on Post-Op Day 2	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9853503Westrich GH, Specht LM, Sharrock NE, Windsor RE, Sculco TP, Haas SB, Trombley JF, Peterson M. Venous haemodynamics after total knee arthroplasty: evaluation of active dorsal to plantar flexion and several mechanical compression devices. J Bone Joint Surg Br. 1998 Nov;80(6):1057-66. doi: 10.1302/0301-620x.80b6.8627.
Background: PubMed 10738427Westrich GH, Specht LM, Sharrock NE, Sculco TP, Salvati EA, Pellicci PM, Trombley JF, Peterson M. Pneumatic compression hemodynamics in total hip arthroplasty. Clin Orthop Relat Res. 2000 Mar;(372):180-91. doi: 10.1097/00003086-200003000-00020.
Background: PubMed 19264711Johanson NA, Lachiewicz PF, Lieberman JR, Lotke PA, Parvizi J, Pellegrini V, Stringer TA, Tornetta P 3rd, Haralson RH 3rd, Watters WC 3rd. Prevention of symptomatic pulmonary embolism in patients undergoing total hip or knee arthroplasty. J Am Acad Orthop Surg. 2009 Mar;17(3):183-96. doi: 10.5435/00124635-200903000-00007.
Background: PubMed 15274256Pitto RP, Hamer H, Heiss-Dunlop W, Kuehle J. Mechanical prophylaxis of deep-vein thrombosis after total hip replacement a randomised clinical trial. J Bone Joint Surg Br. 2004 Jul;86(5):639-42. doi: 10.1302/0301-620x.86b5.14763.
Background: PubMed 15513491Ben-Galim P, Steinberg EL, Rosenblatt Y, Parnes N, Menahem A, Arbel R. A miniature and mobile intermittent pneumatic compression device for the prevention of deep-vein thrombosis after joint replacement. Acta Orthop Scand. 2004 Oct;75(5):584-7. doi: 10.1080/00016470410001466.
Background: PubMed 18534456Froimson MI, Murray TG, Fazekas AF. Venous thromboembolic disease reduction with a portable pneumatic compression device. J Arthroplasty. 2009 Feb;24(2):310-6. doi: 10.1016/j.arth.2007.10.030. Epub 2008 Apr 8.
Background: PubMed 14603195Murakami M, McDill TL, Cindrick-Pounds L, Loran DB, Woodside KJ, Mileski WJ, Hunter GC, Killewich LA. Deep venous thrombosis prophylaxis in trauma: improved compliance with a novel miniaturized pneumatic compression device. J Vasc Surg. 2003 Nov;38(5):923-7. doi: 10.1016/s0741-5214(03)00792-4.
Background: PubMed 8288662Colwell CW Jr, Spiro TE, Trowbridge AA, Morris BA, Kwaan HC, Blaha JD, Comerota AJ, Skoutakis VA. Use of enoxaparin, a low-molecular-weight heparin, and unfractionated heparin for the prevention of deep venous thrombosis after elective hip replacement. A clinical trial comparing efficacy and safety. Enoxaparin Clinical Trial Group. J Bone Joint Surg Am. 1994 Jan;76(1):3-14. doi: 10.2106/00004623-199401000-00002.
Background: PubMed 18574271Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.
Background: PubMed 15330019Silbersack Y, Taute BM, Hein W, Podhaisky H. Prevention of deep-vein thrombosis after total hip and knee replacement. Low-molecular-weight heparin in combination with intermittent pneumatic compression. J Bone Joint Surg Br. 2004 Aug;86(6):809-12. doi: 10.1302/0301-620x.86b6.13958.
Background: PubMed 18534421Edwards JZ, Pulido PA, Ezzet KA, Copp SN, Walker RH, Colwell CW Jr. Portable compression device and low-molecular-weight heparin compared with low-molecular-weight heparin for thromboprophylaxis after total joint arthroplasty. J Arthroplasty. 2008 Dec;23(8):1122-7. doi: 10.1016/j.arth.2007.11.006. Epub 2008 Apr 2.
VenaFlow Elite Description on DJO Global's websiteLink provided by the sponsor.
ActiveCare+SVT Description on MCS's websiteLink provided by the sponsor.

Related trials for Total Hip Arthroplasty

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lucian Warth, MD study director

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Venous Velocity (time frame: Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02345642, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.