Perioperative Intervention to Improve Post-TKR Support and Function

University of Massachusetts, Worcester

Status and phase

Completed

Phase 2

Conditions

Arthroplasty, Replacement, Knee

Osteoarthritis

Treatments

Behavioral: Patient support sessions

Behavioral: Treatment as usual

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00566826

H 12601 (Other Identifier)

R01AR054479 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

196 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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)