Arthroplasty, Replacement, Knee, Osteoarthritis
Conditions
Keywords
Physical Function, Total Knee Replacement, Physical Activity, Behavioral Support, Arthroplasty, Function, Self-Care
Brief 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.
Interventions
BEHAVIORALPatient support sessions
Patient support sessions aim to enhance patient self-care for independent exercise and physical activity.
BEHAVIORALTreatment as usual
Treatment as usual includes standard care for TKR surgery rehabilitation.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical function (SF36, WOMAC) | Measured at Months 6 and 12 |
Secondary
| Measure | Time frame |
|---|---|
| Physical activity and exercise | Measured at Months 6 and 12 |
Countries
United States
Outcome results
None listed