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| Tracking Information | |||||||||
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| First Received Date † | November 30, 2007 | ||||||||
| Last Updated Date | March 31, 2009 | ||||||||
| Start Date † | June 2008 | ||||||||
| Current Primary Outcome Measures † |
Physical function (SF36, WOMAC) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00566826 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
Physical activity and exercise [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title † | Perioperative Intervention to Improve Post-TKR Support and Function | ||||||||
| Official Title † | Perioperative Intervention to Improve Post-TKR Support and Function | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study | ||||||||
| Condition † |
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| Intervention † |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Estimated Enrollment † | 180 | ||||||||
| Estimated Completion Date | June 2011 | ||||||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00566826 | ||||||||
| Responsible Party | Patricia D. Franklin, MD, University of Massachusetts Medical School | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
| Verification Date | March 2009 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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