NCT01907178

Brief Summary

To investigate postoperative pain management in patients undergoing knee or hip replacement while they are in the hospital and following discharge to their home. Additionally, sample questions will be asked prior to surgery to predict patient's postoperative pain experience.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

June 28, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2015

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

June 28, 2013

Last Update Submit

April 26, 2017

Conditions

Arthropathy of Knee Joint

Keywords

total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Pain scores

    Pain scores (at rest \& with exercise) will be collected during the hospital stay

    during hospital stay (average 3 days)

Secondary Outcomes (2)

  • preoperative anxiety scores

    preoperative

  • Preoperative depression scores

    preoperative

Other Outcomes (1)

  • Pain medication consumption

    during hospital stay (average 3 days)

Study Arms (1)

Postoperative pain management

The postoperative pain level will be assessed during hospitalization and at home, in patients undergoing total knee replacement

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated at Saint Francis Hospital undergoing total knee replacement

You may qualify if:

  • Patients undergoing total knee arthroplasty

You may not qualify if:

  • Patients attending rehabilitation facilities after discharge
  • unwilling or unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06057, United States

Location

Study Officials

  • Sanjay Sinha, MD

    Saint Francis Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2013

First Posted

July 24, 2013

Study Start

July 1, 2014

Primary Completion

June 16, 2015

Study Completion

June 16, 2015

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

US(1)