Physical Therapy Components for Maximum TKR Outcome

March 11, 2021 updated by: Patricia Franklin, University of Massachusetts, Worcester

Defining Components of Physical Therapy Achieving Maximum Function After Total Knee Replacement

The overall goal of this study is to identify what Physical Therapy care components are associated with the best patient-reported functional outcome after Total Knee Replacement (TKR) surgery. The investigators are specifically looking at outcomes at 6 and 12 months after surgery.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

161

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
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients electing total knee replacement at one of participating PT sites.

Description

Inclusion Criteria:

  • Are scheduled to undergo an elective, unilateral primary total knee replacement due to knee osteoarthritis
  • Will receive outpatient PT from a participating physical therapist.
  • Agree to record their exercise and activity for specific time points in the study.

Exclusion Criteria:

  • Total knee replacement scheduled for indications other than OA (e.g., fracture, malignancy, infection, or revision or prior implant)
  • The inability to obtain informed consent due to cognitive conditions.
  • Non-English speakers as the materials used in this project have not yet been tested with non-English speakers
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in overall functional gain at 6 months
Time Frame: 6 month follow-up
Differences in pre-operative to 6 month post -operative functional gain, using the SF-36 Physical Component Summary (PCS) Score by physical therapy regimen.
6 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in knee specific functional gain at 6 months
Time Frame: 6 month follow-up
Differences in pre-operative to 6 month post-operative functional gain, using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) by physical therapy regimen.
6 month follow-up
Differences in knee performance measures at 6 months
Time Frame: 6 month follow-up
Differences in pre-operative to 6-month post -operative knee performance measures using the Physical Therapy Performance Measures (includes a 5 minute stair climbing exercise, a 6 minute walking exercise and a sit to stand exercise) by physical therapy regimen.
6 month follow-up

Collaborators and Investigators

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

Sponsor

University of Massachusetts, Worcester

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Patricia D Franklin, MD, MBA, MPH, University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 8, 2018

Primary Completion (Actual)

December 8, 2020

Study Completion (Actual)

December 8, 2020

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 19, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIH 1 R01 AR071048-01
  • 1R01AR071048-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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