Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT
Primary Purpose
Number of Deep Venous Thrombosis (DVT)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doppler Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Number of Deep Venous Thrombosis (DVT) focused on measuring DVT
Eligibility Criteria
Inclusion Criteria:
- Unilateral partial knee replacement
- Postoperative anticoagulation with aspirin 325 twice daily
- Regional anesthesia
- Inflatable garments worn during hospitalization
Exclusion Criteria:
-Bilateral partial knee replacement
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DVT
Arm Description
Doppler Ultrasound
Outcomes
Primary Outcome Measures
Deep venous thrombosis
Secondary Outcome Measures
body mass index
Full Information
NCT ID
NCT02148757
First Posted
May 23, 2014
Last Updated
March 20, 2017
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT02148757
Brief Title
Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT
Official Title
Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Number of Deep Venous Thrombosis (DVT)
Keywords
DVT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DVT
Arm Type
Other
Arm Description
Doppler Ultrasound
Intervention Type
Procedure
Intervention Name(s)
Doppler Ultrasound
Primary Outcome Measure Information:
Title
Deep venous thrombosis
Time Frame
2-6 weeks after surgery
Secondary Outcome Measure Information:
Title
body mass index
Time Frame
at date of surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral partial knee replacement
Postoperative anticoagulation with aspirin 325 twice daily
Regional anesthesia
Inflatable garments worn during hospitalization
Exclusion Criteria:
-Bilateral partial knee replacement
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT
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