Clinical Trials Directory

Trials / Completed

CompletedNCT00566826

Perioperative Intervention to Improve Post-TKR Support and Function

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
196 (actual)
Sponsor
University of Massachusetts, Worcester · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPatient support sessionsPatient support sessions aim to enhance patient self-care for independent exercise and physical activity.
BEHAVIORALTreatment as usualTreatment as usual includes standard care for TKR surgery rehabilitation.

Timeline

Start date
2008-06-01
Primary completion
2012-08-01
Completion
2012-08-01
First posted
2007-12-04
Last updated
2023-09-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00566826. Inclusion in this directory is not an endorsement.