Perioperative Intervention to Improve Post-TKR Support and Function

August 31, 2023 updated by: Patricia Franklin, University of Massachusetts, Worcester
Knee osteoarthritis is one of the most common causes of disability in older adults. Total knee replacement (TRK) surgery is often an effective solution when persistent pain does not sufficiently improve with non-surgical treatment. Although most TKR surgeries are a success, an estimated 15% to 30% of patients report no clinically significant improvement in function 12 months after a TKR. This study will evaluate the effectiveness of a patient support program in increasing physical function after a TKR surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each year, more than 350,000 adults elect to have TKR surgery to eliminate knee pain and associated disabilities that persist despite ample medical treatment. Common knee problems of people who undergo TKR surgery include osteoarthritis, rheumatic diseases, and sudden or gradual joint injury. Most people who undergo TKR surgery experience immediate and significant decrease in pain, improved joint function, and increased physical activity. However, not all people who undergo TKR surgery report improvement, and there is no one factor that contributes to this variation in functional gain. With the rapid growth in the number of people electing to have TKR surgery and in the number of candidates eligible for TKR, optimal surgical results are both a clinical and public health priority. This study will evaluate the effectiveness of a patient support program emphasizing exercise and emotional health in increasing physical function after TKR surgery.

Participants in this study will be randomly assigned to a TKR patient support program or treatment as usual. The intervention patients will receive a program designed to complement the intensive physical rehabilitation period.

Sessions will aim to help participants enhance their self-management skills for behavior change.

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 2

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 Memorial Health Center; Arthritis and Total Joint 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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Scheduled for TKR surgery with one of University of Massachusetts Memorial Health Center's surgeons prior to study entry

Exclusion Criteria:

  • TKR due to fracture, malignancy, infection, or failure of a previous knee replacement surgery
  • Inability to return home during the rehabilitation period
  • Co-existing conditions that would negate functional improvement with surgery and exercise
  • TKR surgery scheduled on an emergency basis
  • Scheduled for TKR surgeries of both knees at the same time
  • Terminal illness with a life expectancy of less than 1 year
  • Inability to provide informed consent due to dementia or cognitive impairment
  • Planning another TKR or THR surgery within 6 months of study entry
  • Unavailable to complete study procedures (i.e., will be out of the region during the rehabilitation period)

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patient support treatment sessions
Behavioral: Patient support sessions
Patient support sessions aim to enhance patient self-care for independent exercise and physical activity.
Active Comparator: 2
Treatment as usual
Behavioral: Treatment as usual
Treatment as usual includes standard care for TKR surgery rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physical function (SF36, WOMAC)
Time Frame: Measured at Months 6 and 12
Measured at Months 6 and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical activity and exercise
Time Frame: Measured at Months 6 and 12
Measured at Months 6 and 12

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, University of Massachusetts, Worcester
  • Study Director: Milagros C. Rosal, PhD, 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

June 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

November 30, 2007

First Submitted That Met QC Criteria

November 30, 2007

First Posted (Estimated)

December 4, 2007

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AR054479 (U.S. NIH Grant/Contract)
  • H 12601 (Other Identifier: University of Massachusetts Medical School)

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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