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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00566826 |
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.
Condition | Intervention | Phase |
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Osteoarthritis Arthroplasty, Replacement, Knee |
Behavioral: Patient support sessions Behavioral: Treatment as usual |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Perioperative Intervention to Improve Post-TKR Support and Function |
Estimated Enrollment: | 180 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patient support treatment sessions
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Behavioral: Patient support sessions
Patient support sessions aim to enhance patient self-care for independent exercise and physical activity.
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2: Active Comparator
Treatment as usual
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Behavioral: Treatment as usual
Treatment as usual includes standard care for TKR surgery rehabilitation.
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Janel Milner | 508-856-2202 | janel.milner@umassmed.edu |
United States, Massachusetts | |
University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center | Recruiting |
Worcester, Massachusetts, United States, 01655 | |
Sub-Investigator: David C. Ayers, MD |
Principal Investigator: | Patricia D. Franklin, MD | University of Massachusetts Medical School |
Study Director: | Milagros C. Rosal, PhD | University of Massachusetts Medical School |
Responsible Party: | University of Massachusetts Medical School ( Patricia D. Franklin, MD ) |
Study ID Numbers: | R01 AR054479 |
Study First Received: | November 30, 2007 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00566826 |
Health Authority: | United States: Federal Government |
Physical Function Total Knee Replacement Physical Activity Behavioral Support |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |