NCT02148757

Brief Summary

Purpose of this study is to determine the incidence of deep venous thrombosis after partial knee replacement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

4.2 years

First QC Date

May 23, 2014

Last Update Submit

March 20, 2017

Conditions

Number of Deep Venous Thrombosis (DVT)

Keywords

DVT

Outcome Measures

Primary Outcomes (1)

  • Deep venous thrombosis

    2-6 weeks after surgery

Secondary Outcomes (1)

  • body mass index

    at date of surgery

Study Arms (1)

DVT

OTHER

Doppler Ultrasound

Procedure: Doppler Ultrasound

Interventions

Doppler UltrasoundPROCEDURE
DVT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral partial knee replacement
  • Postoperative anticoagulation with aspirin 325 twice daily
  • Regional anesthesia
  • Inflatable garments worn during hospitalization

You may not qualify if:

  • Bilateral partial knee replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

May 28, 2014

Study Start

June 1, 2011

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

US(1)