Skip to main content
OpenTrials
Completed

NCT Number: NCT00566826

Perioperative Intervention to Improve Post-TKR Support and Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Arthroplasty, Replacement, Knee Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Rheumatic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Patient support sessions

Behavioral

Patient support sessions aim to enhance patient self-care for independent exercise and physical activity.

Treatment as Usual

Behavioral

Treatment as usual includes standard care for TKR surgery rehabilitation.

Primary outcomes

  1. Physical function (SF36, WOMAC)

    Time frame: Measured at Months 6 and 12

Secondary outcomes

  1. Physical activity and exercise

    Time frame: Measured at Months 6 and 12

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

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

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 4, 2007
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.