Knee ArthroplastyNCT01003080
Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial
A study testing Aquamantys Device in people with Knee Arthroplasty, run by Montefiore Medical Center at 2 sites in United States.
Trial summary
The use of Aquamantys during total knee arthroplasty will reduce drain output and the necessity for blood transfusions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Aquamantys Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Apr 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient indicated for total knee arthroplasty
Who cannot join
- Patients undergoing revision total knee arthroplasty
- Patients with blood disorders
- Patients on chronic anti-thrombotic medication such as Coumadin
- Patients with a history of deep vein thrombosis
- Patients with a history of pulmonary embolism
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jack D. Weiler Hospital-Division of Montefiore Medical Center
The Bronx, New York, 10461
Montefiore Medical Center
The Bronx, New York, 10467
About this study
The use of Aquamantys during total knee arthroplasty will reduce drain output and the necessity for blood transfusions.
- Conditions
- Knee Arthroplasty
- Being tested
- Aquamantys Device, Standard of care treatment for hemostasis during a total knee arthroplasty.
- Keywords
- The evaluation of hemostasis during total knee arthroplasty using the aquamantys device.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquamantys DeviceDevice
The Aquamantys is used for hemostasis in patients randomized to receive total knee arthroplasty with the device.
Standard of care treatment for hemostasis during a total knee arthroplasty.Other
The active comparator arm will receive the "standard-of-care" for hemostasis during total knee arthroplasty. This is achieved with a unipolar Bovie electrocauterization device.
| Study group | Role | What they receive |
|---|---|---|
| TKA with the Aquamantys for hemostasis | Experimental | This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis. Receives: Device: Aquamantys Device |
| TKA without the Aquamantys for hemostasis | Active comparator | This group will receive total knee arthroplasty using the standard treatment for hemostasis. Receives: Other: Standard of care treatment for hemostasis during a total knee arthroplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drain Output.
This is a measure of the average drain output collected in the first 24 hours following surgery.
Measured: First 24 hours following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionApr 2010
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.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Jin Kim, Montefiore Medical Center
- Investigators
- Sun Jin Kim, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003080
- Sponsor's protocol ID
- 09-05-145
- Status last verified
- Aug 2018
- First submitted
- 27 Oct 2009
- Last updated
- 21 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01003080
- Acronym / sponsor ID
- 09-05-145
- Conditions
- Knee Arthroplasty
- Keywords
- The evaluation of hemostasis during total knee arthroplasty using the aquamantys device.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Posted 7 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of Aquamantys during total knee arthroplasty will reduce drain output and the necessity for blood transfusions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKA with the Aquamantys for hemostasis | Experimental | Device: Aquamantys DeviceThis arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis. |
| TKA without the Aquamantys for hemostasis | Active comparator | Other: Standard of care treatment for hemostasis during a total knee arthroplasty.This group will receive total knee arthroplasty using the standard treatment for hemostasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient indicated for total knee arthroplasty
Key exclusion criteria (5 listed)
- Patients undergoing revision total knee arthroplasty
- Patients with blood disorders
- Patients on chronic anti-thrombotic medication such as Coumadin
- Patients with a history of deep vein thrombosis
- Patients with a history of pulmonary embolism
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 |
|---|---|---|
| Aquamantys DeviceThe Aquamantys is used for hemostasis in patients randomized to receive total knee arthroplasty with the device. | Device | TKA with the Aquamantys for hemostasis |
| Standard of care treatment for hemostasis during a total knee arthroplasty.The active comparator arm will receive the "standard-of-care" for hemostasis during total knee arthroplasty. This is achieved with a unipolar Bovie electrocauterization device. | Other | TKA without the Aquamantys for hemostasis |
Primary outcome
Drain Output.
Time frame: First 24 hours following surgery.
This is a measure of the average drain output collected in the first 24 hours following surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sun Jin Kim, MD principal investigator
Montefiore Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquamantys Device in people with Knee Arthroplasty, run by Montefiore Medical Center at 2 sites in United States.
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 1 inclusion and 5 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 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 7 Apr 2011). 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?
Drain Output. (time frame: First 24 hours following surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2018.