Perioperative Intervention to Improve Post-TKR Support and Function
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|ClinicalTrials.gov Identifier: NCT00566826|
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : February 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Arthroplasty, Replacement, Knee||Behavioral: Patient support sessions Behavioral: Treatment as usual||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||Perioperative Intervention to Improve Post-TKR Support and Function|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
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.
- Physical function (SF36, WOMAC) [ Time Frame: Measured at Months 6 and 12 ]
- Physical activity and exercise [ Time Frame: Measured at Months 6 and 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|