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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR054479 | U.S. NIH Grant/Contract | View source | |
| H 12601 | Other Identifier | University of Massachusetts Medical School |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patient support treatment sessions |
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| 2 | Active Comparator | Treatment as usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient support sessions | Behavioral | Patient support sessions aim to enhance patient self-care for independent exercise and physical activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| Physical function (SF36, WOMAC) | Measured at Months 6 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity and exercise | Measured at Months 6 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia D. Franklin, MD | University of Massachusetts, Worcester | Principal Investigator |
| Milagros C. Rosal, PhD | University of Massachusetts, Worcester | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24132356 | Result | Ayers DC, Li W, Oatis C, Rosal MC, Franklin PD. Patient-reported outcomes after total knee replacement vary on the basis of preoperative coexisting disease in the lumbar spine and other nonoperatively treated joints: the need for a musculoskeletal comorbidity index. J Bone Joint Surg Am. 2013 Oct 16;95(20):1833-7. doi: 10.2106/JBJS.L.01007. | |
| 29712620 | Result | Zheng H, Rosal MC, Li W, Borg A, Yang W, Ayers DC, Franklin PD. A Web-Based Treatment Decision Support Tool for Patients With Advanced Knee Arthritis: Evaluation of User Interface and Content Design. JMIR Hum Factors. 2018 Apr 30;5(2):e17. doi: 10.2196/humanfactors.8568. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual | Behavioral | Treatment as usual includes standard care for TKR surgery rehabilitation. |
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| 30281207 | Derived | Oatis CA, Johnson JK, DeWan T, Donahue K, Li W, Franklin PD. Characteristics of Usual Physical Therapy Post-Total Knee Replacement and Their Associations With Functional Outcomes. Arthritis Care Res (Hoboken). 2019 Sep;71(9):1171-1177. doi: 10.1002/acr.23761. |
| 21981909 | Derived | Rosal MC, Ayers D, Li W, Oatis C, Borg A, Zheng H, Franklin P. A randomized clinical trial of a peri-operative behavioral intervention to improve physical activity adherence and functional outcomes following total knee replacement. BMC Musculoskelet Disord. 2011 Oct 7;12:226. doi: 10.1186/1471-2474-12-226. |
| D001519 |
| Behavior |