Number of Deep Venous Thrombosis (DVT)NCT02148757
Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT
A study testing Doppler Ultrasound in people with Number of Deep Venous Thrombosis (DVT), run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Purpose of this study is to determine the incidence of deep venous thrombosis after partial knee replacement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Number of Deep Venous Thrombosis (DVT)
- What is being tested?
- Doppler Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unilateral partial knee replacement
- Postoperative anticoagulation with aspirin 325 twice daily
- Regional anesthesia
- Inflatable garments worn during hospitalization
Who cannot join
- -Bilateral partial knee replacement
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Purpose of this study is to determine the incidence of deep venous thrombosis after partial knee replacement.
Read the detailed description
Doppler Ultrasound will be performed 2-6 weeks after surgery.
- Conditions
- Number of Deep Venous Thrombosis (DVT)
- Being tested
- Doppler Ultrasound
- Keywords
- DVT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler UltrasoundProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| DVT | Other | Doppler Ultrasound Receives: Procedure: Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep venous thrombosis
Measured: 2-6 weeks after surgery
Secondary outcomes (1)
body mass index
Measured: at date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJun 2011
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Number of Deep Venous Thrombosis (DVT)Studies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148757
- Sponsor's protocol ID
- 10093
- Other IDs
- IRB 10093
- Status last verified
- Mar 2017
- First submitted
- 23 May 2014
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT
- ClinicalTrials.gov ID
- NCT02148757
- Acronym / sponsor ID
- 10093
- Conditions
- Number of Deep Venous Thrombosis (DVT)
- Keywords
- DVT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of this study is to determine the incidence of deep venous thrombosis after partial knee replacement.
Detailed description
Doppler Ultrasound will be performed 2-6 weeks after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DVT | Other | Procedure: Doppler UltrasoundDoppler Ultrasound |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral partial knee replacement
- Postoperative anticoagulation with aspirin 325 twice daily
- Regional anesthesia
- Inflatable garments worn during hospitalization
Key exclusion criteria (1 listed)
- -Bilateral partial knee replacement
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 |
|---|---|---|
| Doppler Ultrasound | Procedure or surgery | DVT |
Primary outcome
Deep venous thrombosis
Time frame: 2-6 weeks after surgery
1 secondary outcome
body mass index
Time frame: at date of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler Ultrasound in people with Number of Deep Venous Thrombosis (DVT), run by Hospital for Special Surgery, New York at 1 site 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 4 inclusion and 1 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 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Deep venous thrombosis (time frame: 2-6 weeks after 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 Mar 2017.