Doppler Ultrasound Following Unicondylar Knee Replacement... | NCT02148757

Studies
Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT

NCT02148757

Sponsor

Hospital for Special Surgery, New York

Status

Completed

Last Update Posted

Mar 21, 2017Actual

Enrollment

112Actual

Phase

Not Applicable

Conditions

Number of Deep Venous Thrombosis (DVT)

Interventions

Doppler Ultrasound

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB 10093	Other Grant/Funding Number	Hospital for Special Surgeryt

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Aug 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

May 23, 2014

First Submission Date that Met QC Criteria

May 27, 2014

First Posted Date

May 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2017

Last Update Posted Date

Mar 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DVT	Other	Doppler Ultrasound	Procedure: Doppler Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doppler Ultrasound	Procedure		DVT

Measure	Description	Time Frame
Deep venous thrombosis		2-6 weeks after surgery

Measure	Description	Time Frame
body mass index		at date of surgery

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital for Special Surgery		New York	New York	10021	United States