Ambulation Versus Standing on Postoperative Day 0 (PT on POD 0)

March 27, 2019 updated by: Craig J Della Valle, MD, Rush University Medical Center

Ambulation Versus Standing on Postoperative Day 0: A Randomized, Controlled Trial

The purpose of this study is to determine the impact of the timing of physical therapy (PT) initiation on postoperative length of stay and the time to physical therapy clearance following total knee replacement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • scheduled for primary TKA (Total Knee Arthroplasty) for any degenerative condition
  • Anesthesia for TKA is Spinal + Regional block (Adductor Canal Block)

Exclusion Criteria:

  • require assistive devices (walker, wheelchair) for ambulation preoperatively
  • planning to go to a subacute nursing facility or acute rehab facility following surgery
  • < 18 yrs of age
  • not willing to participate or unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ambulation
Patients will initiate inpatient physical therapy on the day of their surgery including attempted ambulation with an assistive device that is supervised by a physical therapist.
Other: Physical Therapy
Patients will initiate inpatient physical therapy on the day of their surgery including attempted ambulation with an assistive device that is supervised by a physical therapist.
Active Comparator: Standing
Patients will initiate inpatient physical therapy on postoperative day 1. On the day of their surgery they will dangle their feet over the edge of the bed with supervision of nursing.
Other: Standing
Patients will initiate inpatient physical therapy on postoperative day 1. On the day of their surgery they will dangle their feet over the edge of the bed with supervision of nursing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospitalization Stay
Time Frame: 5 days
The length of time patients stay in the hospital will be recorded and compared between groups.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 1 week
Patients will be prospectively surveyed at discharge and asked questions about their satisfaction with their care during their hospitalization.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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