Perioperative Intervention to Improve Post-TKR Support and Function
|Osteoarthritis Arthroplasty, Replacement, Knee||Behavioral: Patient support sessions Behavioral: Treatment as usual||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Perioperative Intervention to Improve Post-TKR Support and Function|
- Physical function (SF36, WOMAC) [ Time Frame: Measured at Months 6 and 12 ]
- Physical activity and exercise [ Time Frame: Measured at Months 6 and 12 ]
|Study Start Date:||June 2008|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566826
|United States, Massachusetts|
|University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Patricia D. Franklin, MD||University of Massachusetts, Worcester|
|Study Director:||Milagros C. Rosal, PhD||University of Massachusetts, Worcester|