NCT02879188

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
394

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

August 22, 2016

Last Update Submit

March 27, 2019

Conditions

Keywords

degenerative joint diseasetotal knee arthroplastyphysical therapyarthroplasty, replacement, knee

Outcome Measures

Primary Outcomes (1)

  • Length of Hospitalization Stay

    The length of time patients stay in the hospital will be recorded and compared between groups.

    5 days

Secondary Outcomes (1)

  • Patient Satisfaction

    1 week

Study Arms (2)

Ambulation

EXPERIMENTAL

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

Standing

ACTIVE COMPARATOR

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

Interventions

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.

Ambulation

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.

Standing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

OsteoarthritisJoint Diseases

Interventions

Physical Therapy ModalitiesStanding Position

Condition Hierarchy (Ancestors)

ArthritisMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationPostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Craig Della Valle, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopaedic Surgery; Chief, Division of Adult Reconstructive Surgery

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2018

Study Completion

September 1, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations